MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN; SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS

Model Number VBJR051002A

Device Problems Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

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

Event Date 07/17/2020

Event Type  malfunction  

Event Description

This elderly female presented to the operating room with a pre-operative diagnosis of critical right limb ischemia and non-healing wound of the right heel.Following the performance of a 1.7 mm laser atherectomy through the superficial femoral artery occluded vessel, it was dilated with an end vac pacific extreme 4.0 300 mm balloon.Once the channel was open the vessel was entered with a 5 mm 527 mm 6 fr gore via band endoprosthesis.It was ballooned with a 5 mm x 250 mm and for tach admiral extreme balloon.An arteriogram was performed.When the proximal balloon was removed resistance was felt.Upon removing, it was noted that the tip was dislodged.After multiple attempts with catheter, an amrose snare was used and was able to deliver the tip to the destination catheter and remove the destination catheter.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC; 301 airport rd; elkton MD 21921
• MDR Report Key: 10331888
• MDR Text Key: 200624858
• Report Number: 10331888
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VBJR051002A
• Device Catalogue Number: VBJR051002A
• Device Lot Number: 22200784
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 61