MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Device Problem Complete Blockage (1094)

Patient Problems Aneurysm (1708); Thrombosis (2100); Stenosis (2263)

Event Date 11/23/2018

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be completed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.Note: article publish date is 23 november 2018.Publish date will be used as the date of event.

Event Description

The following article was reviewed: "endovascular reconstruction of subclavian artery aneurysms in patients with atrial thoracic outlet syndrome" (meena archie, m.D.; hugh gelagert, m.D.; presented at the southern california vascular surgical society 2018 meeting in los angeles; ann vasc surg 2019; 57: 10-15; published online: 32 november 2018) was reviewed.The aim of the study was to report the results with endovascular subclavian artery reconstruction in arterial thoracic outlet syndrome (tos) patients over a 10-year period with attention to surgical approach and late results.The article identifies two patients required reintervention for stent thrombosis (1.5 months, 36 months) and 1 required balloon angioplasty for in-stent restenosis (24 months).Wall-stents (boston scientific, newton, ma) and viabahn were implanted.

Event Description

The following article was reviewed: "endovascular reconstruction of subclavian artery aneurysms in patients with atrial thoracic outlet syndrome" (meena archie, m.D.; hugh gelagert, m.D.; presented at the southern california vascular surgical society 2018 meeting in los angeles; ann vasc surg 2019; 57: 10-15; published online: 23 november 2018) was reviewed.This report captures 1 patient who suffered early stent thrombosis at 6 weeks postoperatively.This was successfully recanalized with overnight catheter-directed thrombolysis.Additionally, 1 stent-graft thrombosis was noted at 43 months in a patient who had discontinued his antiplatelet medication.Thrombosis was managed with overnight catheter-directed thrombolysis.The patient has been maintained on clopidogrel with no recurrent symptoms.Note: both wallstent¿ endoprosthesis (boston scientific, newton, ma) and gore® viabahn® endoprosthesis (w.L.Gore, flagstaff, az) were implanted during the study.

Manufacturer Narrative

Corrected data: b2 - outcomes attributed to adverse event b3 - date of event b5 - describe event or problem h6 - patient code 1 h6 - patient code 2 h6 - patient code 3.Additional manufacturer narrative: a1 - patient identifier a2 - age at time of event a3 - sex g5 - combination product g5 - pre-1938 g5 - otc product.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8861787
• MDR Text Key: 153404199
• Report Number: 2017233-2019-00599
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• 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): Other; Required Intervention
• Patient Age: 39 YR