MAUDE Adverse Event Report: ST. JUDE MEDICAL / ABBOTT VASCULAR ANGIOSEAL VIP

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 08/29/2019

Event Type  Injury  

Event Description

On august 27, a (b)(6) y/o male underwent transaortic valve replacement.On august 29th, the pt underwent repair of the right external iliac and common femoral artery, thrombectomy of distal iliac artery and common femoral artery, fasciotomies of the medial, lateral, and posterior compartments, and removal of angio-seal device occluding the external iliac artery.

• Brand Name: ANGIOSEAL VIP
• Type of Device: ANGIOSEAL
• Manufacturer (Section D): ST. JUDE MEDICAL / ABBOTT VASCULAR; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 9086928
• MDR Text Key: 159753521
• Report Number: 9086928
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/30/2019
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 87