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COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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| Model Number N/A |
| Device Problems
Fracture (1260); Material Separation (1562)
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| Patient Problems
Abdominal Pain (1685); Insufficient Information (4580)
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| Event Date 08/05/2022 |
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Event Type
Injury
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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It was reported that the suprarenal stent of an unknown zenith main body graft had separated into two pieces and was no longer sutured to the main body graft.The zenith graft was initially placed at an unknown date in another facility.The patient was referred to the complaint facility for complex endovascular aortic repair.Imaging provided by the customer showed tortuous infrarenal abdominal aortic anatomy and ballerina placement of iliac leg grafts due to tortuosity.The secondary intervention to repair the aorta was completed successfully.The patient was reported to have left the operating room in good condition.Additional information regarding event and patient details has been requested, but is currently unavailable.
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Event Description
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Procedural notes were provided on 18sep2022.Preoperative diagnosis: symptomatic pararenal abdominal aortic aneurysm.Postoperative diagnosis: symptomatic pararenal abdominal aortic aneurysm.Procedures: 1.Aortogram with c02.2.Deployment of a cook 36mm x 95mm main body with a right sided 20mm x 90 limb and a left sided 24mm x 74mm graft.3.Percutaneous access for both groin exposures.4.Intravascular ultrasound evaluation of the abdominal aorta.Total contrast used: 15cc of contrast.Estimated blood loss: 600cc.Indication: male with a history of a previous abdominal aortic repair done open.He came for progressive and new inset abdominal pain with radiation to his back.He was found, on non-contrast ct scan, to have a large dumbbell shaped abdominal aortic aneurysm that extended near the renal arteries.The upper portion of the aneurysm measured a maximum diameter about 6.5cm, an the lower portion was about the same, but irregular shaped.The patient also has significant chronic renal failure with creatinine in excess of 4, however, he is still making urine and not on dialysis.He is very functional and active, and the concern was if there was a way to treat this without doing it open, given the potential morbidity and mortality, as this would require clamping above the renals, celiac and possibly even the mesenteric arteries.We elected to begin with a repair of the lower aneurysm and spare the pararenal portion.Should he develop fulminant renal failure and be dialysis dependent, we would contemplate covering the renal arteries to see if we could seal there.We had partial imaging with carbon dioxide and intravascular ultrasound, however, the specific anatomy was unclear.We ultimately elected to proceed to the operating room, with further diagnostic testing and an attempt at endovascular repair.Description of index procedure (occurring in 2018): the patient was brought to the operating room, and after undergoing general anesthesia, his bilateral groins were prepped and draped in a sterile fashion.Using ultrasound guidance, we accessed bilateral common femoral arteries and subsequently placed a 5fr sheath.We then attempted to advance a wire into his very tortuous iliac vessels, however, this was not possible.Therefore, we first advanced a floppy guidewire in a retrograde fashion, followed by catheter, followed by a wire, followed by 2 suture mediated closure systems in each common femoral artery.Each time this was done, it required a catheter advancement through the tortuous anatomy that he had and the lower aneurysm that had blown out the terminal portion of the aorta.Ultimately, we were able to fire 2 suture mediated closure systems in each groin and subsequently places a 9fr sheath into the terminal aorta.We cannulated the surgical aortic graft that he had and subsequently placed 2 stiff wires and a pigtail was positioned in the pararenal portion.We performed multiple c02 imaging studies to mark out the location of the renal vessels.We subsequently advanced over one of the stiff wires an intravascular ultrasound that confirmed that the images that we were seeing were accurate.We marked on the screen the location of the renal vessel that was the lowest, and in this case, it seemed to be the right side based on the curve of the aorta.Once we identified this at the top of the screen, we determined that we should be able to seal within the graft that the patient has with a 36mm x 95mm main body, we elected to advance this over the left side.We attempted to advance it after dilating our tract with 22fr dilators.However, the graft would not tract.Of note, we attempted to remove the suprarenal fixation in order to minimize the metal in the top part.However, it is possible that the sheath was not perfectly sealed and therefore it was catching.We removed the graft and examined it and noted that it was a little bit irregular, suggesting that it was catching on one of the angles.We elected to try one more time with a new graft with the suprarenal fixation and this was advanced with quite a bit of difficulty, but ultimately it entered better than the previous.We advanced it into the abdominal aorta and deployed it with a slight angulation to the right side for cannulation.Once we deployed the graft, we attempted to withdraw our pigtail and cannulate.However we fell into the large inferior aneurysm which made it essentially impossible to cannulate the gate, as well as the aorta proper, due to the multiple angles associated to his extraordinarily tortuous aorta and the big terminal aneurysm with the fixed midportion into the graft.After multiple attempts and different catheter approached, we ultimately decided to go up and over and snare our wire.Therefore using a buddy wire system, we punctured the seal of the left sided graft and subsequently advanced a wire and a catheter.We got up and over the graft bifurcation and advanced our wire into the large aneurysm.Once we confirmed that our wire was close to the previous cannulation that we were able to get to, we advanced a 7french sheath and then advanced a snare.The snare captured the wire and we pulled it though and through from left to right.Once we had through and through access, we advanced our sheath into the right gate and subsequently exchanged for a stiff wire and we now had access to the right side.We then advanced the pigtail and did a retrograde angiogram using c02 and marked the location of the internal iliac artery bifurcation.We estimated our length, and on the right side, we chose a 20mm diameter by 90 mm limb, and this was deployed just at the internal iliac origin.We repeated our c02 angiogram and confirmed that there was flow into the internal iliac, but we were certainly up close.On the left side, we changed our image intensifier and advanced the pigtail and did a c02 angiography, which suggested we should use a 24 x 74 graft, we deployed this into the flared out portion right above the bifurcation, to advance the cook coda balloon on either side, particularly the left side, due to the multiple turns of his calcified vessels, and ultimately got inside the graft.We flared the top gently, knowing that it was inside of an aneurysm, and we dilated the midportion, and each individual limb.Once we were finished, we did a completion c02 angiogram which suggested a type 1a endoleak running down the left side of the graft.This was very concerning, given that it appeared that we were not sealing into the patient's surgical graft.We changed the angle, repeated it and got the same result.Therefore, i attempted to go and cannulate the sac using a catheter and while i was able to advance a wire, nothing would track into the sac.Ultimately, i elected to do a confirmation injection with contrast and advanced the pigtail above the location of the graft and performed a completion angiogram.The angiogram demonstrated that there seemed to be a good seal at the top and if anything, there was a retrograde type 1b at the bottom.The location is unclear, but it is possible the left iliac limb is not quite sealing low enough.However, we wanted to ensure that the internal iliac was left open on the left side given that the right side was so close.The endoleak was not dramatic, therefore, we elected to leave it as is and close.We withdrew catheters, wires and sheaths and tightened our suture mediated closure system on the left side.He had some bleeding at the end, suggesting one of the suture mediated closure systems did not fire properly, but ultimately it was not that bad, so we held pressure and removed the wire.One the right side, a similar thing happened, where one of the wires was broken and we did a post procedure suture mediated closure system and fired one additional one in the anterior/posterior position.We then held gentle pressure and this actually stopped all flow down the orifice.We then evaluated for pulses.The patient had a strong dorsalis pedis pulses bilaterally suggesting nice patent vessels.Therefore, we reversed with heparin and held pressure some more.The patient tolerated the procedure well.There were no complications.The physician was present during the entire procedure and performed or directed every step.Preoperative diagnosis: juxtarenal and distal abdominal aortic aneurysm after previous repair.Postoperative diagnosis: juxtarenal and distal abdominal aortic aneurysm after previous repair.Procedure: 1.Diagnostic aortogram using carbon dioxide.2.Intravascular ultrasound of the abdominal aorta and right iliac vessels.3, retrograde angiogram of the left common femoral.Common iliac and iliac bifurcation via left-sided puncture, estimated blood loss: approximately 30cc.Indication: the 82-year-old male patient who was found to have a large 6.7cm aortic aneurysm that has appeared in the proximal and distal ends of a previous repair.The proximal region is juxtarenal and offers no traditional aortic neck based on noncontrast imaging and the distal portion is irregular.He has abdominal pain and is symptomatic from this.Therefore, in order to attempt for case planning, we took him to this operating room for an angiogram given that his creatinine is greater than 3.Description of the procedure: patient was brought to the operating room and after undergoing moderate sedation, his bilateral groins were prepped and draped in a sterile fashion.Using ultrasound guidance, we accessed the right common femoral artery and advanced a 5fr sheath.Using a floppy wire, we traversed his tortuous iliac vessels until we reached the abdominal aorta.It was a little bit difficult given his large aneurysms.However, we advanced a pigtail catheter after first placing a support catheter and subsequently performed an aortogram using carbon dioxide at the mesenteric plate.This revealed his luminal diameters to us which i will summarize as follows: he has a right-sided 4mm renal artery lumen, he has a 6mm left renal artery lumen.He has an aortic diameter at the short neck of approximately 31mm, 5mm neck.The tube graft has an approximate intraluminal diameter of 32mm.The right common iliac artery measures approximately 3cm and has a dilated portion with an 18mm lumen and a distal portion measuring approximately 15mm.The access vessel on the right external iliac artery is 9-10 mm lumen.The left common iliac artery measures approximately 16 mm and is approximately 25 mm in length.The left external iliac artery measures 13 mm in diameter.The approximate length for the left lowest renal to the aortic bifurcation is approximately 140 cm, not necessarily following center line.After the carbon dioxide imaging, we noted that the left side was not able to be visualized with the carbon dioxide.Therefore, we elected to place a catheter into the left common femoral artery.We did so by using ultrasound, identified the left common femoral artery and placed a needle and glidewire in a retrograde fashion.We subsequently placed a 5 french catheter and a 3-way stopcock.We then did a retrograde angiogram using carbon dioxide and got the measurements mentioned above.In order to better determine the length of the neck and such, we elected to use intravascular ultrasound.A 8french sheath was advanced into the abdominal aorta from the right side and subsequently we advanced an 8fr intravascular ultrasound probe.We identified the location of the renal arteries and the mesenteric artery as well a the celiac artery.We then measured length and diameters as mentioned above and took single shots to aid in measurements in the future.We then withdrew the ultrasound intravascular probe.Once we did this, we elected to identify the patency of the renal arteries and to do this we did a short burst of true contrast for a total of 7cc.The injection revealed a widely patent left renal artery.However, we could not quite identify the right renal artery based on injection; however, carbon dioxide would imply that it is patent.Once this procedure was completed, at this time, we reversed his heparin, withdrew the catheters, wires, and exchanged the right 8french sheath for a short sheath and subsequently deployed a proglide closure device.Subsequently, we removed the sheath, held pressure on both sides, and the patient tolerated the procedure well.He had palpable pulses at the end.There were no complications.Physician was present during the entire procedure and performed, or directed every step.Arterial line placement procedure: indication: frequent blood draws, intra-arterial pressure monitoring.Confirmed correct patient, procedure side and site.Performed by the physician assistant.Patient signed informed consent.Preparation and technique: local anesthesia given.Sterile preparation of 2% chlorhexidine gluconate, 1% lidocaine without epinephrine was instilled at site.Placed in the right radial artery in the right forearm extended and wrist dorsiflexed.The catheter was advanced without difficulty.Arterial pressure was transduced.Placement was confirmed by an appropriate arterial waveform tracing.Changed over wire and secured in place.Sterile dressing was placed.Procedure tolerated well estimated blood loss: 3ml.Follow up: time spent performing the above procedure was not included in separately documented patient care reported in the patient record.Total time spent on procedure was 25 min.No complication was noted.Clincal diagnosis: abdominal aortic aneurysm, acute pain, coronary artery disease (cad), chronic gerd, chronic kidney disease (ckd), hypertension, hypertensive emergency, type 2 diabetes mellitus arterial line placement procedure: indication: intra-arterial pressure monitoring.Confirmed correct patient, procedure side and site.Safety procedures were followed.Performed by the nurse practitioner.Patient signed informed consent.Preparation and technique: artery palpated and collateral circulation intact.Local anesthesia given.Sterile preparation of site was 70% isopropyl alcohol and 2% chlorhexidine gluconate, with full drapes, gown, gloves and mask.Local anesthesia using 1% lidocaine without epinephrine was instilled at site.Placement in the right radial artery in the right forearm extended and wrist dorsiflexed.An angiocatheter was used to cannulate the artery.The catheter was advanced without difficulty.Arterial pressure was transduced.Placement was confirmed by an appropriate arterial waveform tracing.The catheter was secured in place.A sterile dressing was placed and a biopatch applied.The patient tolerated the procedure well.Estimated blood loss: 3ml.Follow up: time spent performing the above procedure was not included in separately documented patient care reported in the patient record.No complication was noted.Clinical diagnosis: abdominal aortic aneurysm, hypertension.
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Manufacturer Narrative
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Correction: h6 - annex e.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 - annex a.Investigation ¿ evaluation.(b)(6) medical center informed cook on 05aug2022 of an event with a male patient involving an zenith main body graft (tffb-36-95-zt; lot unknown).In 2018, a complex endovascular aortic repair procedure was performed, and the graft was initially placed in the patient.The suprarenal crown of the graft separated into two pieces and was no longer sutured to the main body graft at a later date.A secondary intervention to repair the aorta was completed successfully, and the patient was reported to have left the operating room in good condition.Imaging provided by the customer showed tortuous infrarenal abdominal aortic anatomy and ballerina placement of iliac leg grafts due to tortuosity.The patient had the following pre-existing conditions thoraco-abdominal aortic aneurysm, acute pain, coronary artery disease (cad), chronic gerd, chronic kidney disease (ckd) with creatinine > 3-4, hypertension, hypertensive emergency, and type 2 diabetes mellitus.It¿s unsure if the patient was compliant with follow-up protocol per the ifu of the device.A review of the complaint history, documentation, drawing, instructions for use (ifu), manufacturing instructions (mi), quality control procedures, and specifications were conducted during the investigation.The complaint device was not returned for investigation; therefore, no physical examination could be conducted.However, medical imaging was provided by the customer for expert review.The complaint of suprarenal stent fracture is confirmed.The complaint of suprarenal and sealing stent separation is not confirmed.The tffb was implanted intentionally between 0mm and 5.15mm above a juxtarenal aaa to treat the ruptured lower portion of the dumbbell shaped aaa and yet preserve renal function.Between 2018 and 2022, the acknowledged unexcluded juxtarenal aneurysm grew, and the aorta lengthened.The suprarenal and sealing stents were settled in the aneurysm sac.Given the aortic lengthening and multiple barb fractures, the initial phase of settling likely included extraction.Outside the ifu, features including tffb sealing stent implantation in the aneurysm, no preimplantation cta, and implantation angiography resulted in the settling and fractures.However, the initial intent of sealing the distal rupture was successful.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook could not complete a review of the device history record (dhr) due to lack of lot information provided.Detections are in place to inspect each device prior to distribution.Therefore, cook concludes that the device was manufactured to specification.Evidence provided by the complaint facility, device failure analysis, complaint history, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Cook also reviewed product labeling.The device was packaged with ifu t_zaaaf_rev5.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.4 warnings and precautions.4.1 general: additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.4.2 patient selection, treatment and follow-up: key anatomical elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (>60 degrees for infrarenal neck to axis of aaa or >45 degrees for suprarenal neck relative to the immediate infrarenal neck); short proximal aortic neck (<15 mm); an inverted funnel shape (greater than 10% increase in diameter over 15 mm of proximal aortic neck length); and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.In the presence of anatomical limitations, a longer neck may be required to obtain adequate sealing and fixation.Irregular calcification and/or plaque may compromise the attachment and sealing at the fixation sites.Necks exhibiting these key anatomical elements may be more conducive to graft migration or endoleak.Successful patient selection requires specific imaging and accurate measurements; please see section 4.3 pre-procedure measurement techniques and imaging.4.3 pre-procedure measurement techniques and imaging: lengths: the long-term performance of this endovascular graft has not yet been established.All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysm or changes in the structure or position of the endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.Specific follow-up guidelines are described in section 11, imaging guidelines and postoperative follow-up.After endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft.At a minimum, annual imaging is required, including: 1) abdominal radiographs to examine device integrity (separation between components, stent fracture or barb separation) and 2) contrast and non-contrast ct to examine aneurysm changes, perigraft flow, patency, tortuosity, and progressive disease.If renal complications or other factors preclude the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information.4.4 device selection: strict adherence to the zenith flex aaa endovascular graft ifu sizing guide is strongly recommended when selecting the appropriate device size (tables 10.5.1 through 10.5.2).Appropriate device oversizing has been incorporated into the ifu sizing guide.Sizing outside of this range can result in endoleak, fracture, migration, device infolding or compression.4.5 implant procedure: do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or delivery system.Stop and assess the cause of resistance; vessel, catheter or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis or in calcified or tortuous vessels.Repositioning the stent graft distally after partial deployment of the covered proximal stent may result in damage to the stent graft and/or vessel injury.Fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft, and desired procedural outcome.The zenith alpha abdominal endovascular graft incorporates a suprarenal stent with fixation barbs.Exercise extreme caution when manipulating interventional and angiographic devices in the region of the suprarenal stent.Avoid damaging the graft or disturbing graft positioning after placement in the event re-instrumentation (secondary intervention) of the graft is necessary.5 potential adverse events: aneurysm enlargement, aneurysm rupture and death, claudication (e.G., buttock, lower limb), endoleak.Endoprosthesis: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion; component separation.Surgical conversion to open repair.7 patient selection and treatment.7.1 individualization of treatment.Additional considerations for patient selection include but are not limited to: patient¿s age and life expectancy, comorbidities (e.G., cardiac, pulmonary, or renal insufficiency prior to surgery, morbid obesity), patient¿s suitability for open surgical repair, patient¿s anatomical suitability for endovascular repair, ability to tolerate general, regional, or local anesthesia, iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with a 16 fr (6.0 mm od) or 17 fr (6.5 mm od) vascular introducer sheath.8 patient counseling information: patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter.Patients should be told that regular and consistent follow-up is critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of aaas.At a minimum, annual imaging and adherence to routine postoperative follow-up requirements is required and should be considered a lifelong commitment to the patient¿s health and well-being.Physicians should refer patients to the patient guide regarding risks occurring during or after implantation of the device.Procedure-related risks include cardiac, pulmonary, neurologic, bowel and bleeding complications.Device-related risks include occlusion, endoleak, aneurysm enlargement, fracture, potential for reintervention and open surgical conversion, rupture, and death (see section 5, potential adverse events).The physician should complete the patient id card and give it to the patient so that he/she can carry it with him/her at all times.The patient should refer to the card anytime he/she visits additional health practitioners, particularly for any additional diagnostic procedures (e.G., mri).12 imaging guidelines and postoperative follow-up: 12.1 general: the long-term performance of this endovascular graft has not yet been established.All patients should advise that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up.Physicians should evaluate patients on an individual basis and prescribe their follow-up relative to the needs and circumstances of each individual patient.The recommended imaging schedule is presented in table 11.1.1.This schedule continues to be the minimum requirement for patient follow-up and should be maintained even in the absence of clinical symptoms (e.G., pain, numbness, weakness).Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.The combination of contrast and non-contrast ct imaging provides information on aneurysm diameter change, endoleak, patency, tortuosity, progressive disease, fixation length and other morphological changes.After review of the ifu, cook has concluded the device labeling contains appropriate warnings, precautions and instructions to the user related to the reported failure.Based on the information provided and the results of the investigation, cook could not determine a definitive cause for the reported failure.Possible contributing factors include patient anatomy and/or medical procedure.It was reported the patient had an extremely tortuous anatomy.The image reviewer confirmed the suprarenal stent fracture but was not able to confirm suprarenal sealing stent separation.In addition, the image reviewer noted, ¿the aneurysm was severely angulated.¿ the appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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