MAUDE Adverse Event Report: AV-TEMECULA-CT RX HERCULINK ELITE RENAL STENT SYSTEM

Catalog Number 1011493-12

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Visual inspection was performed on the returned device.The dislodged stent was confirmed.The loose stent was not confirmed as the stent was off the balloon.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported loose balloon and dislodgment.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the herculink elite stent delivery system was prepared for use and no issues were noted.The herculink elite stent delivery system was advanced onto the guide wire and it was noted that the stent was loose on the balloon.The stent then dislodged from the balloon, at a location outside the patient anatomy.There was no difficulty noted during advancement over the guide wire.The device and dislodged stent were removed from the guide wire without difficulty.A second same size herculink elite stent delivery system was then used without issue.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

• Brand Name: RX HERCULINK ELITE RENAL STENT SYSTEM
• Type of Device: RENAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5583320
• MDR Text Key: 43221252
• Report Number: 2024168-2016-02459
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 1011493-12
• Device Lot Number: 5021961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR