MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G55241
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 type 3 endoleak occurred on a zenith flex with spiral-z technology aaa endovascular graft iliac leg following a fenestrated endovascular aneurysm repair (fevar) procedure.During the procedure on (b)(6) 2019, the patient received 5 cook devices and 2 competitor devices, including a main body device, a distal body device, a right iliac leg graft, a left iliac zenith flex with spiral-z technology aaa endovascular graft (zsle-20-56-zt), two covered stents, and a vascular self-expanding stent.It was noted the bilateral common iliacs were tortuous (left greater than the right).An angiogram revealed the superior mesenteric artery to be patent.An aortogram showed patency of the bilateral renal artery stents.A left lower extremity angiogram revealed patency of the left iliac limb and left iliac artery.The patient was extubated in hemodynamically stable condition and taken to the post anesthesia care unit in hemodynamically stable condition.On (b)(6) 2019 (2 months post implant procedure), a ct scan demonstrated stable repair with slight decrease of the excluded aneurysm sac.Some stenosis was noted in the superior mesenteric artery.On (b)(6) 2019 (5 months post implant procedure), a ct scan showed a reduction in her abdominal aortic aneurysm size to 5.9 x 6cm, down from 6.2 x 6.4cm.There was no evidence of a type i or type ii endoleak."questionable" left external iliac artery stenosis was noted at the end of the endograft at an area of a sharp bend.It was reported as being 50%-75% stenosis, and having a dissection though no actual dissection was seen.A soft left iliac "bruit" was heard.On (b)(6) 2021, the patient was discovered unconscious at home by a family member and brought to the hospital.Imaging revealed an enlarged aneurysm sac and device component separation.A type iii endoleak was identified between the main body and left iliac leg device.The patient has refused treatment.No other adverse effects were reported for this incident.The main body device is reported under manufacturer report # 9680654-2021-00016.
Additional Manufacturer Narrative
Correction: upon further investigation, this event no longer meets the reporting criteria.During review of returned imaging, the expert image reviewer noted that the ct scan identified the reported endoleak to be between proximal and distal zfen components, not the zsle-20-56-zt.The zfen components are not manufactured by cook inc.Therefore, this device was not involved in the reported endoleak, and no other problems with this device were detected.As such, no further reports regarding this event will be submitted.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.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12529269
• Report Number: 1820334-2021-02220
• Device Sequence Number: 11037904
• Product Code: MIH
• UDI-Device Identifier: 10827002552415
• UDI-Public: (01)10827002552415(17)211207(10)9335062
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2021
• Device Model Number: G55241
• Device Catalogue Number: ZSLE-20-56-ZT
• Device Lot Number: 9335062
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/01/2021
• 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: 10MM BALLOON; 21G NEEDLE; 5FR MICROPUNCTURE ACCESS SET; 6FR SHEATH; 8X2MM BALLOON; 9X2MM BALLOON; AMPLATZ WIRE; ANGLED GLIDE WIRE; BENTSON WIRE; CODA BALLOON; COOK ZFEN-D-12-45-76-C; COOK ZFEN-P-2-28-124-R; COOK ZIV6-35-80-6-20; COOK ZSLE-16-74-ZT; ICAST STENT (QT.2); IVUS CATHETER; KUMPE CATHETER; PROGLIDE CLOSURE DEVICES (QT.2); ROSEN WIRE; VANSHIE 3 CATHETER; VANSHIE 4 CATHETER
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 54