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

Catalog Number PHB051002

Device Problems Occlusion Within Device (1423); Sticking (1597)

Patient Problems Occlusion (1984); Vascular Dissection (3160)

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient was presented with an occluded gore® viabahn® endoprosthesis which was implanted within the right popliteal artery approximately two years ago in another hospital.It was stated that the medical device occlusion was intended to be treated with a gore® tigris® vascular stent.It was reported to gore that the device occlusion was predialated with a 5x150 balloon and that the gore® tigris® vascular stent was inserted through a 6fr introducer sheath and advanced over a 0.035 stiff guidewire by using a cross over approach.It was stated that the patient¿s vessel itself did not indicate any calcification or tortuosity.It was reported to gore that when device deployment was initiated the stent didn¿t continue to deploy completely as the deployment wheel became stuck and couldn¿t be rotated any further.It was stated that the ¿safety catch¿ was even tried to be pulled without any success.It was reported to gore that the physician was able to retrieve the partial deployed tigris device from the patient¿s vessel through the introducer sheath, where a lot of force was required, without performing a conversion of the patient¿s leg.Consequently, as the patient¿s vessel layers were injured, the popliteal artery and superficial femoral artery occluded.A thrombectomy was performed and the lesion was treated by implanting another stent (supera stent).It was stated that the patient is doing well following the procedure and that a good blood flow was established.

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.When physically evaluated upon return, the following observations were made: the gore® viabahn® endoprosthesis was kinked at multiple locations along the catheter, including near the strain relief.The inner shaft was flattened proximal to features.The tear tube was severed at the thumbwheel.Destructive disassembly of the outer sheath and strain relief was required to remove the tear tube from the outer sheath at the location of the strain relief.Approximately 32.5 mm of the distal end of the stent was uncovered.The coupler bond was unable to be removed without destructive removal of the outer sheath.The coupler bond appeared unremarkable.

• Brand Name: GORE® TIGRIS® VASCULAR STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL CENTRAL B/P; 1500 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6950236
• MDR Text Key: 90421268
• Report Number: 2017233-2017-00537
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P160004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2019
• Device Catalogue Number: PHB051002
• Device Lot Number: 15914248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2016
• 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: 48 YR
• Patient Weight: 80