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

Catalog Number 1011504-18

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no other similar incidents.There was no damage noted to the stent delivery system (sds) during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulty to deploy appear to be related to circumstances of the procedure.In this case, is likely that during advancement the sds encountered resistance with the anatomy and/or the other devices used in the procedure causing the stent to become loose and/or moved from the crimped location, resulting in the stent deploying distal to the intended location.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a lesion in the mildly tortuous right renal artery.A.014 spartacore guide wire was used with the incompatible 8 x 19mm on 80cm omnilink elite balloon-expandable stent system (bes) due to vessel sizing.The bes experienced support and turning issues, but did not face resistance.A non-abbott support catheter was used to exchange guide wires; however, the.014 guide wire was not replaced with the recommended.035 guide wire due to poor positioning of the support catheter and fear of losing wire access if attempted.The omnilink bes was removed without issues.The same spartacore guide wire had no issues and was used with the 7 x 18mm on 80cm herculink bes, with no issues.During deployment, the balloon was intentionally inflated slowly, and the stent moved 4mm distal from where intended, partially outside of the target lesion.A 7 x 15mm herculink bes was deployed proximally to the first herculink stent to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: 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: 8714253
• MDR Text Key: 148544960
• Report Number: 2024168-2019-04877
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648078354
• UDI-Public: 08717648078354
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/19/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 1011504-18
• Device Lot Number: 7110861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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: 69 YR