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

Catalog Number PAJ061002

Device Problems Difficult to Insert (1316); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.The device was received for analysis and the investigation is in process.Further information will be provided.(b)(4).

Event Description

On (b)(6) 2017, a patient was being treated for a superficial femoral artery (sfa) occlusion using a gore® viabahn® endoprosthesis with heparin bioactive surface.The patient had a history of a popliteal aneurysm.Reportedly, the patient had a thrombosed popliteal artery and the anterior tibial artery required a thrombectomy procedure.10mg of thrombolytics (tpa) was delivered via power pulse followed 10-15 minutes later with mechanical thrombectomy (angiojet) with good result.Then, a 6mm x 10cm device was intended to be used in the popliteal artery.At some point during the implant process, the deployment line was pulled, however the device only partially deployed 2cm, and could not be removed from the patient through the 6fr flexor sheath.The physician attempted to remove the sheath and the stent delivery mechanism together, however, the partially deployed stent prevented this.The physician cut the stent delivery system in order to advance a larger 10fr sheath over the delivery system in an attempt to remove the stent which was successful.Reportedly, the physician successfully deployed another gore® viabahn® endoprosthesis with heparin bioactive surface (paj061502/ 16391537) into the sfa and closed with a proglide.The patient did have a pseudoaneurysm the following day which required thrombin injection.The patient tolerated the procedure.

Manufacturer Narrative

The device was sent to gore for the engineering analysis and it was observed that a deployment knob with a section of the deployment line still attached.The deployment line segment measured approximately 40.5cm.The deployment line appeared to be cut.A separate segment of deployment line remained attached at the endoprosthesis.The catheter was returned in 2 pieces.One piece consisted of the deployment hub connected to a section of proximal catheter tubing that measured approximately 5.5cm.The tubing appeared cut.The second piece measured approximately 119.5cm from the cut end of the catheter tubing to the end of the distal tip.The endoprosthesis was still mounted on the distal shaft.The endoprosthesis was longitudinally compressed towards the transition.Approximately 1.2cm of the distal shaft, upon which the endoprosthesis was mounted, was exposed at the distal tip.Approximately 2.5cm of the endoprosthesis on the distal tip end was expanded.The transition end of the endoprosthesis was constrained by the inner braided constraining line, which was compressed.At 1.3cm and 2.0cm from the tip end, the endoprosthesis was radially constricted.Some strut rows in the partially deployed section of the endoprosthesis were detached from the graft.A segment of deployment line measuring 104.5cm was attached to the inner braided constraining line by a single fiber.Where the fiber joined the full deployment line, the deployment line appeared to be unraveled with fiber breaks.The opposite end of the deployment line appeared cut.The single fiber measured approximately 26.5cm.Further deployment was not able to be continued with traction on the single fiber at the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified.

• 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: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7105446
• MDR Text Key: 94944205
• Report Number: 2017233-2017-00639
• 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
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2019
• Device Catalogue Number: PAJ061002
• Device Lot Number: 15980134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2016
• 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: 65 YR