MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Alteration In Body Temperature (2682)

Event Date 09/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).As the devices were not returned, no evaluation of the devices could be performed.

Event Description

The following literature article was reviewed: "select type i and type iii endoleaks at the completion of fenestrated endovascular aneurysm repair resolve spontaneously." marc l.Schermerhorn et al.Journal of vascular surgery article in press submitted jun 29, 2018; accepted sep 29, 2018.Objective: the society for vascular surgery reporting standards for endovascular aneurysm repair (evar) consider the presence of a type i or type iii endoleak a technical failure.However, the nature and implications of these endoleaks in fenestrated evar (fevar) are not well understood.Fifty-two patients were included; mean age was 75 6 8 years, 75% were male, and 91% were white.Of 146 visceral vessels (100 renal arteries and 46 superior mesenteric arteries), 145 (99%) were preserved with 103 fenestrations and 43 scallops; 102 (70%) target vessels were stented.After implantation of all device components, 31 patients (60%) had evidence of type i or type iii endoleak.Twelve patients (39%) underwent further intervention at the index procedure, and three endoleaks resolved completely.Twenty-eight patients (54%) had a type i or type iii endoleak on completion angiography.There were no differences between patients with and without completion endoleaks in baseline demographics, graft design, neck anatomy, or proportion of cases performed within the instructions for use of the device.Perioperative mortality was 1.9%.On initial postoperative imaging, 27 of 28 (96%) endoleaks resolved spontaneously.One small, persistent type ia or type iii endoleak was identified on postoperative day 27 and was observed.This endoleak had resolved completely on computed tomography angiography 6 months postoperatively.In patients without a completion endoleak, one type ia endoleak secondary to graft infolding was discovered on postoperative imaging and was successfully treated with placement of endoanchors and palmaz stent.Median follow-up was 269 days.No additional type i or type iii endoleaks were identified in any patient for the duration of follow-up.

Manufacturer Narrative

Method code 2 - 4117.

Event Description

The following literature article was reviewed: "select type i and type iii endoleaks at the completion of fenestrated endovascular aneurysm repair resolve spontaneously." marc l.Schermerhorn et al.Journal of vascular surgery article in press submitted jun 29, 2018; accepted sep 29, 2018.Objective: the society for vascular surgery reporting standards for endovascular aneurysm repair (evar) consider the presence of a type i or type iii endoleak a technical failure.However, the nature and implications of these endoleaks in fenestrated evar (fevar) are not well understood.From 2013 to 2018, 52 patients underwent fevar with the zfen device.The mean age was 75 years, 75% were male, and 91% were white.Of 146 visceral vessels (100 renal arteries and 46 superior mesenteric arteries), 145 (99%) were preserved with 103 fenestrations and 43 scallops; 102 (70%) target vessels were stented.The mean target vessels per procedure was 2.8.All stented renal arteries were stented with covered stents (96 icast, 1 gore® viabahn® vbx balloon expandable endoprosthesis [w.L.Gore & associates].For superior mesenteric arteries, one (20% = 9) stent was covered and four (80% = 37) were baremetal stents (1 icast, 2 express [boston scientific, marlborough, mass], 1 palmaz blue [cordis], 1 xact [abbott vascular].After implantation of all device components, 31 patients (60%) had evidence of type i or type iii endoleak.Twelve patients (39%) underwent further intervention at the index procedure, and three endoleaks resolved completely.Twenty-eight patients (54%) had a type i or type iii endoleak on completion angiography.There were no differences between patients with and without completion endoleaks in baseline demographics, graft design, neck anatomy, or proportion of cases performed within the instructions for use of the device.Perioperative mortality was 1.9%.On initial postoperative imaging, 27 of 28 (96%) endoleaks resolved spontaneously.One small, persistent type ia or type iii endoleak was identified on postoperative day 27 and was observed.This endoleak had resolved completely on computed tomography angiography 6 months postoperatively.In patients without a completion endoleak, one type ia endoleak secondary to graft infolding was discovered on postoperative imaging and was successfully treated with placement of endoanchors and palmaz stent.Median follow-up was 269 days.No additional type i or type iii endoleaks were identified in any patient for the duration of follow-up.The article does not indicate how many endoleaks were attributed to gore® viabahn® vbx balloon expandable endoprosthesis and no confirmation of interventions involving vbx device.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9869565
• MDR Text Key: 196480231
• Report Number: 2017233-2020-00211
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR