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

Catalog Number PAJR052502E

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423)

Patient Problem No Code Available (3191)

Event Date 11/10/2017

Event Type  Injury  

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 a long occlusion within the right superficial femoral artery which was intended to be treated with a gore® viabahn® endoprosthesis.The medical device was inserted through a 6fr introducer sheath, where a cross over approach was used, and advanced to the target lesion over a 0.018 guidewire (victoray).After implantation of the gore® viabahn® endoprosthesis it was recognized that the occluded lesion is too long to be treated with just one medical device.Therefore a second gore® viabahn® endoprosthesis was implanted.It was sated that no abnormalities were recognized during device insertion, advancement and deplyoment.It was reported to gore that after 3 minutes of device implantation, both gore® viabahn® endoprostheses partially occluded.After 15 minutes a total occlusion of the devices were diagnosed.It was stated that a recanalisation was performed unsuccessfully.Consequently, the patient underwent a bypass procedure.It was reported to gore that the patient did not received acetylsalicylic acid or platelet (function) inhibitors.The hospital will investigate further if a heparin-induced thrombocytopenia type ii might be the reason for the early device occlusion.The patient was doing well following the procedure.

• 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: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7124858
• MDR Text Key: 95170433
• Report Number: 2017233-2017-00651
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2017

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: 04/11/2020
• Device Catalogue Number: PAJR052502E
• Device Lot Number: 16552486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 70