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

Catalog Number PAH131002

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device is currently in progress.

Event Description

On (b)(6) 2017 a patient was undergoing a popliteal artery aneurysm repair with a gore viabahn endoprosthesis with propaten bioactive surface.Access was obtained via a femoral artery through a 12fr.Sheath over a.035¿ amplatz wire.The first device was placed distally without incident (pah101002 lot 16223198).A second device (pah131002 lot 15440075) was removed from the packaging and prepared as normal with no signs of any issues.It was loaded onto the wire and advanced to the desired location.Deployment was smooth with no tension experienced.The delivery catheter was then removed and once outside the patient it was noticed that the leading end of the catheter and tip were missing.It was noticed on screen that the distal marker was still on the wire in the area of stent deployment.A snare catheter was then back-loaded over the wire to capture the catheter segment which was then removed.Once outside the patient it was noted the tip was now missing and on examination was noted inside the 12fr sheath which was then removed and the tip with it.At this point the procedure was stopped but the patient will require a second procedure to add a final stent due to incomplete treatment of aneurysm.There was no injury to the patient.

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.The engineering evaluation stated the following: the distal shaft, upon which the endoprosthesis was mounted, and the remainder of the delivery catheter assembly were returned.No endoprosthesis, deployment knob, nor deployment line were returned.The catheter assembly was returned in 3 separate pieces: the distal tip, the distal shaft, and the remainder of the delivery catheter assembly.The distal shaft was approximately 11.5 cm long.Neither end of the distal shaft showed melting or disruption of the pebax coating.Manufacturing anomalies were identified that potentially could have contributed to the event.

Manufacturer Narrative

The imaging evaluation stated the following: from the images provided, it appears that the residual piece of the delivery catheter was removed successfully using a snare catheter.There is no evidence of device remaining in the patient from the images provided.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• 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: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6997520
• MDR Text Key: 92068561
• Report Number: 2017233-2017-00578
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2019
• Device Catalogue Number: PAH131002
• Device Lot Number: 15440075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/01/2017; 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2016
• 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 Age: 83 YR