MAUDE Adverse Event Report: ABBOTT VASCULAR PERCLOSE; DEVICE, HEMOSTASIS, VASCULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Calcium Deposits/Calcification (1758)

Event Type  Injury  

Event Description

Medtronic received information that following the implant of a transcatheter bioprosthetic valve, upon groin closure the perclose that was used failed x2, when surgeon exposed the area it was noted that a large piece of calcium was interfering with the closure device.Calcium was removed and a left femoral artery endarterectomy was done without any issues.Ct scan showed that the patient had calcium in the arteries.No additional adverse patient effects have been reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERCLOSE
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 17528411
• MDR Text Key: 321049944
• Report Number: MW5135341
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1