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

Model Number 1011487-18

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2019

Event Type  malfunction  

Event Description

The stent (herculink 4.0 x 18) was advanced to the renal artery and came off the balloon.The balloon delivery and wire was removed.Microsnare inserted but unable to retrieve stent.Stent noted to be in iliac artery.Renal area of concern was stented and due to blood thinners the sheath was sutured in place.Transferred to preop where retained renal stent was removed in the or.

• Brand Name: HERCULINK ELITE
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 8964516
• MDR Text Key: 156627242
• Report Number: 8964516
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1011487-18
• Device Catalogue Number: 1011487-18
• 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: 08/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA