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

Model Number 1011505-18

Device Problems Material Fragmentation (1261); Material Rupture (1546); Obstruction of Flow (2423); Positioning Problem (3009)

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

Event Date 04/17/2017

Event Type  malfunction  

Event Description

During pci of right coronary graft, the graft was dilated with a 5mm balloon then stented through an 8f guide with a 7x18 herculink elite.The balloon ruptured at 14-15 atm.Upon withdrawing balloon, the distal 1/2 tore free and appeared to have become enmeshed in the distal stent struts.It was partially obstructing flow.Attempts to snare the balloon and the distal wire (to loop around the balloon fragment) were unsuccessful and lead to the platinum tip of the wire becoming enmeshed in the stent as well.Ultimately the prior stent, along with the tip of the wire fragment and the distal half of the balloon and were jailed behind the new stent.

• Brand Name: HERCULINK ELITE
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 6525406
• MDR Text Key: 73805520
• Report Number: 6525406
• Device Sequence Number: 1
• Product Code: NIN
• 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: Patient
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: 1011505-18
• Device Catalogue Number: 1011505-18
• Device Lot Number: 7021461
• 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: 04/25/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 161