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

Catalog Number	1011502-12
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.The investigation determined that the reported difficulties were due to case circumstances.The failure to advance was likely due to anatomical conditions, as the lesion site was described as heavily tortuous and heavily calcified.Additionally, it was reported that the stent dislodged during retraction into the guide catheter, which was likely user related.It should be noted that the rx herculink elite instructions for use (ifu) provides the following instructions: should unusual resistance be felt at any time during either lesion access or removal of the delivery system post-stent implantation, the entire system should be removed as a single unit.Failure to follow these steps and / or applying excessive force to the delivery system can potentially result in loss or damage to the stent and / or delivery system components.If it is necessary to retain guide wire position for subsequent vessel access, leave the guide wire in place and remove all other system components.In this case, failing to follow the ifu removal instructions likely contributed to the stent dislodgment.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 lot revealed no other incidents.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 heavily tortuous, heavily calcified lesion in the renal artery.During a percutaneous intervention, the herculink elite stent delivery system (sds) failed to cross the lesion due to anatomy.During sds retraction, resistance was met retracting the device into the guide catheter.During retraction, the herculink elite stent dislodged into the iliac artery.A wire was attempted to retrieve the dislodged herculink elite stent, however, the stent then traveled into the profunda artery.It was decided to leave the stent free floating in the profunda and no additional treatment was provided.Another herculink elite stent was successfully used in replacement.There was no reported adverse patient sequela and no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7945252
• Report Number: 2024168-2018-07760
• Device Sequence Number: 931165
• Product Code: NIN
• UDI-Device Identifier: 08717648078279
• UDI-Public: 08717648078279
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 1011502-12
• Device Lot Number: 8010461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 75