MAUDE Adverse Event Report: COOK INC ENDOVASCULAR DILATOR SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 01/19/2024

Event Type  Death  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): mobile: 0404491695, postal code: 2145.G4- pma/510(k) #: k210734.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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Cook was notified of the rupture of a patient's left external iliac artery during the use of cook products.The patient was 68-year-old female who had been diagnosed with an aortic aneurysm.She did not have significantly tortuosity in her vessels.The diameter of her access vessels were in 5.5- 6mm range.She underwent an endovascular aortic repair (evar) on (b)(6) 2024.A cook fenestrated graft (rpn: fen-thoraco-abdominal-graft) was deployed.For access on the patient's left the physician utilized two cook endovascular dilators jcds-1618-eds-hc and jcds-2022-eds-hc to sequentially increase the access from a 16french to a 22 french.The sequential dilation was being performed to insert a extra larch check flow introducer (rpn: xvcfw-20.0-35-25) that had an outer diameter of 20 french.The outer diameter of the cook 22 french dilator matched the 20 french diameter of the extra large check flow introducer (rpn: xvcfw-20.0-35-25).No problems were noted with the use of the dilators for sequential dilation or the insertion of the extra large check flow introducer (rpn: xvcfw-20.0-35-25).The following arteries were stented uneventfully through the 20 french sheath placed on the left with competitor's covered stents: coeliac, superior mesenteric (sma), left renal, and right renal.The cook fenestrated graft delivery system was removed from the patient's right groin.The bifurcated graft (aaa-bifurcated-graft) was delivered from the right and was deployed successfully.The contralateral gate of the aaa-bifurcated-graft was cannulated from the left groin.Cannulation was confirmed with a cook coda balloon.The cook coda balloon was not used to cannulate the contralateral limb and was not inflated inside the external iliac artery.Shortly after the cannulation, the patient's blood pressure dropped dramatically.Cardiopulmonary resuscitation (cpr) began.The physician's completed an angiogram that appeared to show a ruptured left external iliac artery.The physicians quickly deployed two cook zenith alpha spiral-z endovascular leg grafts, rpn: zisl13-93 & zisl-13-77 to cover the tear and to prevent further blood loss.The ruptured vessel was successfully repaired.However, the patient never stabilized and was declared deceased after approximately a total of 50 minutes of cardiopulmonary resuscitation (cpr).The physician was unable to say what caused the left external iliac rupture and why the patient did not stabilize after the rupture repair.The physician has chosen not to disclose if any cook device caused or contributed in some way to the patient death.The focus of this report is the cook endovascular dilator set (rpn: jcds-2022-eds-hc) that was used for sequential dilatation in the procedure on the left side where the left external iliac artery ruptured.

Manufacturer Narrative

Correction: h6 (annex a).Investigation ¿ evaluation: cook informed on 30jan2024 of incident involving a endovascular dilator set.According to the site, a fenestrated graft was deployed and all four vessels (coeliac, sma, lra, rra) were stented uneventfully with a competitor's covered stents.The fenestrated graft delivery system was removed from right groin and replaced with bifurcated graft delivery system.Before introduction of the 20fr sheath (xvcfw-20.0-35-25) on the left side that was used to cannulate the four fenestrations of the custom made graft, the physician utilized the endovascular dilator sets (g52834 jcds-1618-eds-hc, g52835 jcds-2022-eds-hc) increasing in size sequentially from 16fr-22fr.At this point they felt the dilators went smoothly, so they removed the dilator and put the 20fr sheath up without any noticeable problems.The sheath stayed in place for the remainder of the procedure.The physician cannulated the contralateral gate from the left groin and confirmed cannulation with coda balloon, and shortly after the patient¿s blood pressure dropped dramatically and cpr was commenced.The physician completed an angiogram and identified the ruptured left external iliac artery.Zisl devices were deployed in an attempt to repair the left external iliac rupture once it was noted.The patient underwent 50 minutes of cpr and never stabilized.Patient death was reported.The subject of this complaint (b)(4) is the cook jcds-2022-eds-hc that was used for sequential dilatation in the procedure where the left external iliac artery ruptured and the patient died.Reviews of the complaint history, device history record (dhr), quality control, manufacturing instructions (mi), and instructions for use (ifu), were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.An anatomy sketch and a planning worksheet with still images was provided by the site.The provided information was reviewed by the product manager.The reviewer noted the external iliac artery tapered down to 5.5mm just after the iliac bifurcation.It is possible the vessel was unable to sustain the increased diameter.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.The lot number was not provided; however, an expanded sales search to the customer was able to identify three possible lots.A dhr review was completed for all three final lots and sub-assembly lots.A review revealed 13 possibly related non-conformances in which all affected devices were scrapped.A complaint history search did not identify any other events associated with any of the three possible device lots.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The product ifu, t_eds_rev0 ¿endovascular dilator and sets¿, provides the following information to the user related to the reported failure mode: warnings: do not use if any sign of product damage is visible.This product is a delicate instrument.Avoid forceful angulation.Precautions: the maximum diameter of the instrument or catheter to be introduced should be considered when selecting the dilator size.If resistance is encountered during dilator manipulation, stop and determine the cause before proceeding further.Potential adverse events: potential complications include, but are not limited to: bleeding, risks normally associated with percutaneous diagnostic and/or interventional procedures.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.Based on the available information, no product returned, and the results of the investigation, a definitive root cause was unable to be established.It is possible patient condition/anatomy was a contributing factor.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ENDOVASCULAR DILATOR SET
• Type of Device: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 18691302
• MDR Text Key: 335184961
• Report Number: 1820334-2024-00204
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: JCDS-2022-EDS-HC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BENTLEY BEGRAFT COVERED STENTS; COOK AAA-BIFURCATED-GRAFT LOT AC1146594; COOK FEN-THORACO-ABDOMINAL-GRAFT, LOT AC1146593; COOK RPN: XVCFW-20.0-35-25; COOK RPN: CODA-2-9.0-35-120-32; COOK RPN: JCDS-1618-EDS-HC; COOK RPN: ZISL-13-59 LOT 15546972; COOK RPN: ZISL-13-77 LOT 13938110; COOK RPN: ZISL-13-93 LOT 14845618; COOK RPN:KCFW-6.0-35-55-RB-HFANL1-HC; LUNDERQUIST WIRES; PTA BALLOONS; ROSEN WIRES
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Sex: Female