MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number CEB231410

Device Problems Collapse (1099); Patient-Device Incompatibility (2682)

Patient Problem Occlusion (1984)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

Only the year of birth was provided.Therefore (b)(6) was used.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Event Description

The patient presented on (b)(6) 2019 with an abdominal aortic aneurysm that was successfully treated with gore® excluder® aaa and gore® excluder® iliac branch endoprostheses (ibe).On (b)(6) 2020, follow-up imaging showed that the left external iliac artery and the ipsilateral leg of the gore® excluder® iliac branch component (ceb) appear to be compressed and thrombosed.On (b)(6) 2020, the ceb and external iliac artery were ballooned, a thrombectomy was performed and two advanta stents were successfully implanted.The ceb and the external iliac artery were reportedly patent afterwards.It was stated that the narrow implantation zone of the ceb contributed to the event.The patient tolerated the procedure.

Manufacturer Narrative

Imaging evaluation: intra-operative angiogram images dated (b)(6) 2019, post-implantation cta images dated (b)(6) 2020 and intra-operative angiogram images dated (b)(6) 2020 were provided for evaluation.The evaluation showed the following: intra-operative angiogram dated (b)(6) 2019 appears to show: 10:14:13 there appears to be a non-deployed device in the left external iliac artery (lei)/left common iliac artery (lci).There appears to be an anatomic narrowing in the mid-distal lci on the pre-implant angiogram 11:21:01 post-deployment of ibe components: a narrowing in the lci still appears to be visualized in the ipsilateral limb of the ibe, near the level of the contralateral ibe gate.11:33:21 narrowing in lci still visualized on post-device deployment image.Specific diameter at the narrowed location cannot be determined with angiogram imaging.Post-implantation cta dated (b)(6) 2020 appears to show: there appears to be contrast pooling outside the implanted device in the anterior/right and posterior aneurysmal sac.There appears to be a set of lumbar arteries with contrast at these levels.There appears to be contrast in the ima.It appears to communicate with the anterior pooling in the sac.There appears to be thrombus in the contralateral limb (bridging device) that extends into the lci.The distal marker of the bridging device appears to be at the level of the ibe flow divider markers or slightly distal to this level.The lei appears to be occluded.The occlusion appears to extend to the distal left external iliac artery.The ibe ipsilateral limb, in the lci, appears to be compressed at approx.14mm distal to the ibe flow divider.Lci diameter at the level of compression appears to be 14.3mm ¿ 14.8mm.Intra-operative angiogram dated (b)(6) 2020 appears to show: 16:11:43 there appears to be lack of flow around the edges of the ibe trunk.The ipsilateral limb in the lci/lei appears to be occluded.Narrowing in ibe ipsilateral limb still observed.16:48:41 there appears to be flow in the ibe ipsilateral limb in the lci and distally in the lei.17:19:28 there appears to be possible lack of flow to the edges of the implanted ibe trunk and into the ipsilateral limb in the lci/lei.17:35:25 flow appears to be restored in the lci and lei.

• Brand Name: AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9680822
• MDR Text Key: 178122458
• Report Number: 3013164176-2020-00013
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2022
• Device Catalogue Number: CEB231410
• Device Lot Number: 20564030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR