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

Device Problem Complete Blockage (1094)

Patient Problems Abscess (1690); Obstruction/Occlusion (2422)

Event Date 09/07/2021

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 literature was reviewed.¿consideration about two cases which were performed surgical treatment for infection of viabahn stent graft after evt.¿ jun okatome, et al.Official journal of the japanese society for vascular surgery, 2021: 30(suppl.) p.O48-4.Case 1: the patient was a (b)(6) year old male, on maintenance dialysis for type 2 diabetes.He underwent evt for left lower limb pain (the right groin was punctured and a cross over technique was performed).The following day it was reported that the untreated right lower limb felt cold.An abi exam was performed, but results for the right side were inconclusive.Upon further examination, the right sfa, which had been found to be patent the day before, was occluded.A gore® viabahn® endoprosthesis was implanted in the right sfa.However, the next day, a re-occlusion was confirmed.An additional viabahn stent graft was implanted to treat the occlusion.After the treatment, the symptoms in the lower limbs improved, but fever and inflammatory reaction increased from the day after the final evt.Various tests indicated that an abscess formation was suspected around the stent grafts in the right superficial femoral artery.Although an antibiotic treatment and a puncture drainage were performed, there was no improvement.The right sfa / stent graft resection was performed surgically.Wound treatment continued post operation, and it was later confirmed that the wound was healed.The patient was transferred to the rehabilitation hospital.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12549906
• MDR Text Key: 274024787
• Report Number: 2017233-2021-02411
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 79 YR