MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PAH131002

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906)

Patient Problem Aneurysm (1708)

Event Date 04/15/2015

Event Type  Injury  

Event Description

A patient presented with an aneurysm in the popliteal artery.Two gore® viabahn® endoprostheses were used for the procedure.The first gore® viabahn® endoprosthesis was implanted distally without any problems.It was reported to gore that when device deployment for the second gore® viabahn® endoprosthesis was initiated the deployment stopped after ¾ of the device.A high resistance of the deployment line was recognized and a high force was needed to complete device deployment while the deployment line broke.After deployment of the device the physician described that there was no overlap of the two devices and that the proximal viabahn device looked clinched.He finished the procedure implanting a nitinol stent between the two medical devices.The physician stated that it can be not assured that there is no remaining deployment line back in the patient.

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.Further investigation is being conducted and the information will be included in the final report.Gore received two lot numbers which were delivered to the hospital (lot #13643344 and lot #13643347).According to the hospital it is unclear which lot is involved with the event.Therefore gore is submitting a report for each lot reported.

Manufacturer Narrative

The gore engineers have evaluated the returned device.Their investigation showed following: the c15-285 specimen consisted of the delivery catheter without the endoprosthesis, deployment knob, or deployment line.The catheter was unremarkable.The c15-286 specimen consisted of the deployment knob with attached deployment line (approximately 180 cm length).The line had multiple knots, and the distal end was frayed (see c15-286 pic 1).The identified nature event code is believed to be partial deployment: deployment line stuck.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4767366
• MDR Text Key: 16861515
• Report Number: 2017233-2015-00283
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2018
• Device Catalogue Number: PAH131002
• Device Lot Number: 13643347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• 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
• Treatment: GORE VIABAHN® ENDOPROSTHESIS - 3 (LOT #13643344)
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 80