MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pseudoaneurysm (2605)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following publication was reviewed: a case of perigraft coil embolization was useful for residual extravasation after placement of viabahn for right subclavian artery injury.On an unknown date, the patient presented with an iatrogenic right subclavian artery injury that occurred during cv catheter insertion after lvad and underwent treatment using a gore® viabahn® endoprosthesis (vsx).On an unknown date, during a follow up, ct imaging revealed an increase in bleeding/hematoma in the right thoracic cavity and residual extravasation.On an unknown date, a re-intervention was performed.The angiography imaging of the right subclavian artery revealed a pseudoaneurysm at the location where extravasation was identified by the previous ct imaging.A renegade microcatheter was inserted between the right subclavian artery and the stent graft and embolized with target coil.Post-embolization ct imaging revealed a decrease in bleeding/hematoma in the right thoracic cavity.Patient information has been requested but is not available at this time.

Manufacturer Narrative

B2: selection made for adverse event reporting.Attached original article source.Source: a case of perigraft coil embolization was useful for residual extravasation after placement of viabahn for right subclavian artery injury, the official journal of the japanese society of interventional radiology, 2020: 34(4) p.313.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10792573
• MDR Text Key: 214791823
• Report Number: 2017233-2020-01415
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other