MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G48432
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914); Rupture (2208)
Date of Event	05/04/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: g55231, zsle-13-56-zt, lot 10304782.G55232, zsle-13-74-zt, lot 10154310.G55233, zsle-13-90-zt, lot 13006495.Coda balloon.Cook 20 fr flexor sheath.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that a (b)(6) year-old female patient died after placement of a zenith flex aaa endovascular graft bifurcated main body due to an iliac rupture in the right limb during an aaa repair procedure on (b)(6) 2020.The physician pre-planned the procedure prior to meeting with the cook representative.The right iliac was dilated using a 20 fr flexor sheath (the largest available) to confirm that the vessel would accept the graft as the patient had narrow iliac arteries.After dilation, the sheath was removed.The right iliac was then pre-ballooned to further expand the vessel using a 8x4 balloon.Prolongated inflation was performed and maintained to ensure adequate expansion of the vessel.There was no indication of a vessel rupture during this step.The delivery system was able to be advanced successfully with no issues retrieving the top cap, though it was stated to be a "little tight", but not abnormal.The physician then moved to the ipsilateral side to take a film to mark the right hypogastric artery.The sheath was noted to be in this area, so it was therefor withdrawn slightly.As he backed the sheath down, the patient's blood pressure dropped and an iliac tear was suspected.A coda balloon was immediately placed in the patient's abdomen to tamponade the aorta.Following that, two ipsilateral iliac limbs were placed quickly without issues graft to ensure the tear was completely covered.The patient¿s blood pressure was not restored after both ipsilateral leg grafts were placed.Cpr was conducted and the patient was administered blood for about an hour.Following this, the patient had faint blood pressure and their cardiac rhythm was unable to be restored.Their abdomen never "firmed-up", so bleeding was unable to be located.The patient was ultimately unresponsive to treatment and passed away.Cardiac arrest was suspected by the physician.It was noted that the patient's blood pressure was reported to be in the low 90's both prior to and during main body and contralateral limb implantation.The facility believes that the patient's cause of death can be attributed to the iliac tear and cardiac arrest due to the patient's condition.
Additional Manufacturer Narrative
Additional information: section c.Correction: h6- device code.Investigation / evaluation: this event was reported from the cook representative at (b)(6) hospital in the united states on (b)(6) 2020.It was reported that a patient died after experiencing vessel rupture of the right iliac artery when using a zenith flex aaa endovascular graft bifurcated main body, rpn: tffb-36-95-zt from lot: 9403106.The patient¿s pre-existing conditions included narrow and calcified iliac arteries with no specific stenosis present.The complaint device was being used during an endovascular aneurysm repair (evar) procedure to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2020.Prior to insertion of the tffb-36-95-zt delivery system, the right iliac artery was dilated using a 20 fr cook flexor sheath (rpn and lot unknown) and prolonged balloon inflation.The cook representative stated that there was no evidence of vessel rupture during this step.The tffb-36-95-zt was successfully advanced through the right iliac artery and described as a little tight but not abnormal.The tffb and contralateral zsle grafts were deployed without issue.The cook representative stated that the patient's blood pressure was stable throughout deployment of the tffb-36-95-zt and contralateral zsle-13-56-zt.The physician then moved back to the ipsilateral side to view the level of the right hypogastric (internal iliac) artery and withdrew the main body sheath slightly.After moving the sheath, the patient's blood pressure dropped significantly and an iliac tear was suspected.The physician inserted a coda balloon to tamponade the aorta and quickly deployed two zsle grafts to cover the tear.The patient's blood pressure did not recover after graft placement and blood was administered for about an hour.The patient was unresponsive to treatment and the facility believed that the patient had cardiac arrest.The patient's abdomen never firmed-up / distended and a source of bleeding could not be located.The patient's cause of death was confirmed to be an iliac tear/cardiac arrest and was determined to be "patient condition related".The physician stated that the devices performed as intended and were deployed without difficulty.A review of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi) and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot: (9403106) and the related subassembly lots revealed no recorded non-conformances.A database search found no other events associated with the reported device lot.It should be noted that tffb prefix devices are distributed via one device lots.As there are adequate inspection activities in place, objective evidence that the dhr was fully executed, no related non-conformances, and no other lot-related complaints received from the field, cook has concluded that the device was manufactured to specification and that there is no evidence that non-conforming product exists either in house or in the field.Cook also reviewed product labeling.The product instructions for use (ifu), ¿zenith flex aaa endovascular graft with the z-trak¿ introduction system¿, provides the following information to the user related to the reported failure mode: 2 indications for use: "the zenith flex aaa endovascular graft with the z-trak introduction system is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with the required introduction systems, non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: with a length of at least 15 mm, with a diameter measured outer wall to outer wall of no greater than 32 mm and no less than 18 mm, with an angle less than 60 degrees relative to the long axis of the aneurysm, and with an angle less than 45 degrees relative to the axis of the suprarenal aorta.Iliac artery distal fixation site greater than 10 mm in length and 7.5 - 20 mm in diameter (measured outer wall to outer wall)." 4 warnings and precautions: "4.1 general.Lack of non-contrast ct imaging may result in failure to appreciate iliac or aortic calcification, which may preclude access or reliable device fixation and seal.4.2 patient selection, treatment and follow-up: access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease and / or calcification) should be compatible with vascular access techniques and delivery systems of the profile of a 16 french to 22 french vascular introducer sheath.Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or ay increase the risk of embolization.4.3 implant procedure: do not bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith flex aaa endovascular graft.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 or catheter damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis in calcified of tortuous vessels.Molding balloon use: confirm complete deflation of balloon prior to repositioning.Do not inflate the balloon in vessel outside of the graft, as doing so may cause damage to the vessel.Use the balloon in accordance with its labeling.Use care in inflating the balloon within the graft in the presence of calcification, as excessive inflation may cause damage to the vessel." 5 adverse events: 5.2 potential adverse events "adverse events that may occur and / or require intervention include, but are not limited to: aortic damage, including perforation, dissection, bleeding, rupture, and death death vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula.Vessel damage.Vascular spasm or vascular trauma (e.G., iliofemoral vessel dissection, bleeding, rupture, death)¿.Based on the information provided, no product returned, and the results of the investigation, a definitive root cause for this event was not traced to the device but rather to the procedure and the patient's condition.With reported calcification and narrowing of the right iliac artery, it is possible that the pre-dilation (using a 20fr sheath and prolonged balloon expansion) or advancement of devices (wire guide, 22fr tffb-36-95-zt delivery system) could have contributed to vessel wall weakening or dislodgement of calcification.Without further information, the investigation could not determine if the patient's anatomy was within indication for use for this device.The tear was only observed after withdrawing the tffb sheath, which could have dislodged a segment of calcification or exposed an area of vessel previously dissected during the procedure.Additionally, vessel dissection/perforation is a known inherent risk of using these devices.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10079853
• Report Number: 1820334-2020-00980
• Device Sequence Number: 19766051
• Product Code: MIH
• UDI-Device Identifier: 10827002484327
• UDI-Public: (01)10827002484327(17)210109(10)9403106
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2021
• Device Model Number: G48432
• Device Catalogue Number: TFFB-36-95-ZT
• Device Lot Number: 9403106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR