MAUDE Adverse Event Report: W.L. GORE AND ASSOCIATES INC ENDOPROSTHESIS VIABAHN STENT; CORONARY COVERED STENT

Model Number VBH081002

Device Problems Separation Failure (2547); Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problem Fistula (1862)

Event Date 02/13/2015

Event Type  Injury  

Event Description

During a procedure to improve the flow of the pt's arterial venous fistula, the dr performed angioplasty of the cephalic arch and noted there was extravasation of the contrast.The dr proceeded to place a viabahn 8 x 10 covered stent.After deployment the delivery system of the stent became lodged within the stent and could not be removed.It appeared the stent did not fully expand.The pt's blood pressure and pain levels were increased and the blood pressure could not be medically controlled; therefore, the decision was made to transfer the pt to the hosp via ems.The transferring physician spoke with the radiologist at the hosp who advised that although he tried to expand the stent with a high pressure balloon, he was also unsuccessful in removing the delivery system because the stent would not expand.The delivery system was ultimately removed surgically be a vascular surgeon.The surgeon that performed the procedure advised the transferring physician that he was able to remove the delivery system but decided to leave the stent in place for safety purposes.The pt's avf access was ultimately ligated and plans for a creation of a new fistula are forthcoming.

• Brand Name: ENDOPROSTHESIS VIABAHN STENT
• Type of Device: CORONARY COVERED STENT
• Manufacturer (Section D): W.L. GORE AND ASSOCIATES INC; 1505 n 4th st; flagstaff AZ 86004
• MDR Report Key: 4620796
• MDR Text Key: 5589885
• Report Number: 4620796
• Device Sequence Number: 1
• Product Code: JCT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: VBH081002
• Device Lot Number: 10243639
• Other Device ID Number: 00733132615049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2015
• Distributor Facility Aware Date: 02/13/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 89