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

Catalog Number PHB050402

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2017

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.(b)(4).

Event Description

The patient was presented with an embolism in the upper limb which was intended to be treated with a gore® tigris® vascular stent.The medical device was inserted through a 7fr introducer sheath and advanced over a 0.035 guidewire.It was stated that the patient did not show any calcification or tortuosity of the vessels.It was reported to gore that the gore® tigris® vascular stent was successfully implanted within the femoral artery / popliteal artery.Anyhow it was stated that some force was experienced dewing the deployment mechanism.After the delivery system was removed from the patient¿s vessel, a visual inspection indicated that the distal catheter shaft portion of the medical device was detached.The performed angiography specified that the separated catheter shaft was still on the guidewire.It was stated that the separated portion was retrieved by using a snare device and removed successfully.A second gore® tigris® vascular stent was implanted to finish the procedure.

Manufacturer Narrative

The device was returned for evaluation.When physically evaluated upon return, the following observations were made: the device was kinked at multiple locations along the catheter, including near the strain relief.The inner shaft was severed 118mm from the distal end of the tip.The edge of the distal segment of the inner shaft was smooth.The remainder of the inner shaft was still intact within the outer sheath.The edge of the proximal segment of the inner shaft was smooth.The location of the severance in the inner shaft is consistent with the location of a cutting step in the manufacturing process, in which a deployment tube component is roll cut using a razor blade.During this step, tooling is inserted inside the tube component to protect the inner shaft.Omission of this tooling at the cutting step could result in the inner shaft severance observed in this event.Investigation of manufacturing controls, maintenance records of the tooling, and associate training did not reveal any inconsistencies in the production of this device, and no definitive root cause could be confirmed for this event.The process step was reviewed and no systemic issue was identified.Previous tigris complaints were reviewed for the findings of this investigation, and no other complaints with observations consistent with this issue were identified.This issue is an isolated event that has not been observed historically in the manufacture of tigris devices.Tigris complaints will continue to be monitored for this issue.(b)(4).

Manufacturer Narrative

Date of event was corrected.Check box was selected that medical device is available for evaluation + date when the device was returned.

• 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: 6899868
• MDR Text Key: 88016755
• Report Number: 2017233-2017-00504
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P160004
• 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: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2019
• Device Catalogue Number: PHB050402
• Device Lot Number: 15696369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2016
• 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: 60 YR