MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE HEMOBAHN® ENDOPROSTHESIS

Device Problem Complete Blockage (1094)

Patient Problems Death (1802); Occlusion (1984)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During investigation of this incident, the author stated that the incident was not related, in their opinion, to the device and did not see any relationship with the gore endograft.The patient experienced aaa rupture followed by severe hypotension and anemia, leading to the graft occlusion.An attempt for rescuing the graft was not possible due to the bad general condition, and the amputation was unavoidable.No further information related to this incident will be provided by the author.Since the actual date of incident is not available the date of the article was used as an estimated date of the incident.

Event Description

Within the article ¿endovascular treatment with primary stenting of acutely thrombosed popliteal artery aneurysms¿, published by aaron fargion et al, within the annals of vascular surgery (2017), the published results indicated the following: six male patients, aged between 63 and 88, came to the hospital attention in the last 10 years for acute limb ischemia due to thrombosis of a paa.In all the cases immediate digital subtraction angiography (dsa) was performed, the occlusion was crossed with an angiographic guidewire and, once an adequate distal landing zone was identified in the distal popliteal artery, a primary stenting was performed by using a gore® viabahn® endoprosthesis or gore® hemobahn®.Technical success was achieved in all the cases.One perioperative thrombosis leading to major amputation occurred, and the patient died 4 days later.The mean follow-up of the remaining 5 patients was 28.6 months, with a primary patency rate of 60% and a secondary patency 52 rate of 80%.The second patient, (b)(6), with coronary artery disease (cad), arterial hypertension, copd and a concomitant abdominal aortic aneurysm (aaa), which contraindicated the use of pre-operative thrombolysis, was hospitalized for acute limb ischemia.Duplex scanning revealed a thrombosed distal superficial femoral artery aneurysm (maximum diameter 21 mm) and 3 run-off vessels.The aneurysm was successfully excluded with a hemobahn stent-graft (10 cm).In the first postoperative day an emergent open repair for sudden rupture of the aaa was successfully performed.After 48 hours in the intensive care unit, occlusion of the popliteal graft occurred, leading to irreversible ischemia requiring above-the-knee amputation.The patient died 4 days later due to multi-organ failure.

• Brand Name: GORE HEMOBAHN® ENDOPROSTHESIS
• Type of Device: A
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6922066
• MDR Text Key: 88403675
• Report Number: 2017233-2017-00524
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR