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

Catalog Number VBJR051502A

Device Problems Failure to Unfold or Unwrap (1669); Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be performed as no lot number information was provided.The device(s) was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.All information has been placed on file for use in tracking and trending.Mw5090252.

Event Description

Gore received a voluntary medwatch (mw5090252) from fda reporting the following: in cardiovascular lab, the physician attempted to deploy a 5mm x 15cm viabahn stent.The stent was properly positioned, but when physician attempted to deploy, the deployment apparatus (string) broke.This left the device partially (about 3cm) deployed and primarily undeployed and non-retrievable.Pt to operating room for open repair and removal.

Manufacturer Narrative

Review of the manufacturing records indicated the device met pre-release specifications.The investigation is ongoing.

Manufacturer Narrative

Corrected data: h1.Type of reportable event.Additional manufacturer narrative: b2.Outcomes attributed to adverse event.

Manufacturer Narrative

Corrected data: d10.Device available for evaluation? (do not send to fda).D10.Returned to manufacturer on: (mm/dd/yyyy).H3.Device evaluated by manufacturer? additional manufacturer narrative: examination of the returned device revealed the following: the deployment knob, deployment line, delivery catheter, approximately 8.5 cm of guidewire, and flushing apparatus attached to the deployment port were returned.The guidewire and flushing apparatus were not evaluated as they are not gore products.There was approximately 159 cm of deployment line returned with a 1 cm single fiber at the end of the deployment line.The delivery catheter appeared to be cut at the transition.The endoprosthesis and the distal shaft , upon which the endoprosthesis is mounted, were returned in two sections.The first section was approximately 8.5 cm long and included part of the transition with the distal shaft exposed approximately 0.5 cm.The second section was approximately 11 cm long with 4 cm of distal shaft coming out of the endoprosthesis.The endoprosthesis on the second section was expanded approximately 6.5 cm and still had 1 cm of the endoprosthesis still compressed.The first section of the endoprosthesis was still constrained.There was a 9 cm single fiber coming off of the expanded portion of the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.Based on the engineer evaluation of the information obtained during the investigation, no product design or manufacturing anomalies were detected.

Manufacturer Narrative

Corrected data: b1.Adverse event and/or product problem.H1.Type of reportable event.Additional manufacturer narrative: b5.Describe event or problem.

Event Description

Rfa (right femoral artery) occlusion was being treated.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9318471
• MDR Text Key: 203349100
• Report Number: 2017233-2019-01136
• 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
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2022
• Device Catalogue Number: VBJR051502A
• Device Lot Number: 21006947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• 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
• Patient Age: 70 YR
• Patient Weight: 92