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

Catalog Number	1011493-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual, dimensional, and functional inspection was performed on the returned device.The damaged stent and difficulty removing was confirmed.The failure to advance was unable to replicate in a testing environment.The investigation determined that the reported difficulties were due to case circumstances.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.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 or Problem Description
It was reported that the procedure was to treat a moderately calcified proximal renal artery.A 5.0 x 18 mm herculink elite stent delivery system could not cross the lesion due to the anatomy and when removing the device the stent got stuck at the distal end of the guiding catheter and the proximal end of the stent flared.The delivery system was pulled back into the guiding catheter which caused the distal end of the guide to fold back on itself so the entire system including the guide wire were removed as a single unit.Another guide wire, guiding catheter and 5.0 x 18 mm herculink elite were successfully used to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: RENAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6159653
• Report Number: 2024168-2016-08771
• Device Sequence Number: 439904
• Product Code: NIN
• UDI-Device Identifier: 08717648078026
• UDI-Public: (01)08717648078026(17)190630(10)6071361
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 1011493-18
• Device Lot Number: 6071361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2016
• Initial Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: CHOICE PTGUIDE CATHETER: 6F
• Patient Age: 75 YR
• Patient Weight: 83