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

Catalog Number	1011499-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual inspection was performed on the returned device.The reported tear or break was confirmed.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.The investigation determined that the reported difficulties were due to case circumstances.
Event or Problem Description
It was reported that the procedure was to treat a renal artery.During advancement of the 6.0 x 15 mm herculink elite stent delivery system (sds) it was observed on angiography that there was a buckling or bowing of the distal end of the catheter and what appeared to be a short wire sticking out proximal to the rapid exchange port.There was no resistance felt during advancement.The sds was removed from the anatomy in one piece without any adverse patient effects.It was believed that either the inner member had separated and that could be the small wire that is sticking out from the shaft.A new same size herculink sds was used to successfully complete the case.No adverse patient effects or clinically significant delay in the procedure were reported.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: 6096159
• Report Number: 2024168-2016-07894
• Device Sequence Number: 10834837
• Product Code: NIN
• UDI-Device Identifier: 08717648078194
• UDI-Public: (01)08717648078194(17)190731(10)6081761
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/11/2016

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: 07/31/2019
• Device Catalogue Number: 1011499-15
• Device Lot Number: 6081761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2016
• Initial Report FDA Received Date: 11/11/2016
• 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 CATHETER: 6FR
• Patient Age: 69 YR
• Patient Weight: 102