MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. IMPRA® EPTFE VASCULAR GRAFTS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number CFT4547C

Device Problem Output Problem (3005)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 02/23/2022

Event Type  malfunction  

Event Description

This is an (b)(6) year-old gentleman who has had a left upper arm av graft for a few years and was noted to have a defect, possibly in the mid portion of the graft with a "bubble" that was concerning for possible infection and risk of bleeding.He has had a little bit of oozing from the area, but the graft has been used without difficulty and the patient had no evidence of bacteremia or gross infection.The affected area seems to have worsened over time.The patient was advised on multiple occasions to see me for evaluation and possible treatment of this issue, but now that he is hospitalized for mental status changes it was felt that he could be seen and treated as well as needed.  description of procedure: the patient was taken to the operating room and given iv ancef for antibiotic prophylaxis.His left arm was prepped and draped in the usual fashion.A tourniquet was present in the room.After a timeout was performed, we injected the skin surrounding the affected area with 1% lidocaine and the patient was sedated.An ellipse was made around the affected area and revealed a hole in the graft.We obtained manual pressure and the patient was given 3000 units of iv heparin.Three minutes later, a sterile tourniquet was applied close to the axilla to stop oozing and bleeding and it was then inflated to 250 mmhg after with the patient's arm was esmarched.No further bleeding was noted and we noted there was a large defect in the graft that could not be salvaged and by definition this is an infected graft, so that portion was excised, but to gain control proximally and distally we needed to find healthy graft to ligate.This was done proximally towards the arterial portion of the graft and distally towards the venous end of the graft where 0 silk ligatures were applied after mobilization of the graft was performed.All wounds were irrigated with ancef and closed in layers including inverted interrupted 3-0 vicryl sutures to approximate subcutaneous tissue, followed by 3-0 nylon mattress sutures for skin closure.Only the portion of the graft affected by the defect was removed.The rest of the graft was ligated.Sterile dressing was applied and an arm brace was applied loosely to prevent the patient from bending his arm.Good distal perfusion was noted.The patient tolerated the procedure well and was transferred to recovery room in stable condition.Blood loss was 50 ml.All counts were correct at the end the case.

• Brand Name: IMPRA® EPTFE VASCULAR GRAFTS
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st; tempe AZ 85281
• MDR Report Key: 13757298
• MDR Text Key: 287129500
• Report Number: 13757298
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2022

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 Model Number: CFT4547C
• Device Catalogue Number: CFT4547C
• Device Lot Number: VTCQ0450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: Black Or African American