MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HERCULINK ELITE; STENT, RENAL

Model Number 1011504-18

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 03/22/2019

Event Type  malfunction  

Event Description

Stent placed in celiac artery in mesentery.Stent deployed without issue.Balloon malfunction on removal prolonging time of procedure.Balloon was able to be retrieved.

• Brand Name: HERCULINK ELITE
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside dr.; santa clara CA 95054
• MDR Report Key: 8543570
• MDR Text Key: 142893701
• Report Number: 8543570
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/08/2019

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 Operator: Health Professional
• Device Model Number: 1011504-18
• Device Catalogue Number: 1011504-18
• Device Lot Number: 6080561
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA