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

Catalog Number 1011528-12

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The resistance with the guide wire was not able to be confirmed due to the condition of the returned device.The tip detachment was confirmed.Based on a visual and dimensional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The results of the query of similar incidents in the complaint handling database for this lot did not indicate a manufacturing issue.It should be noted that the rx herculink elite instructions for use (ifu) warns to carefully inspect the rx herculink elite peripheral stent system prior to use to verify that the stent has not been damaged in shipment and that the device dimensions are suitable for the specific procedure.Take care to avoid unnecessary handling.Based on the reviewed information, no product deficiency was identified.

Event Description

It was reported that during the procedure to treat a renal artery via humeral artery access, after flushing a 0.014in.Spartacore 300cm guide wire and guide wire lumen of a 5.0mm x 12mm x 135cm rx herculink elite stent system, the rx herculink was advanced onto the guide wire, however, resistance was felt against the guide wire during advancement.Though no force was applied during advancement, the tip of the herculink elite was noted to be detached (while outside of patient anatomy).The detached tip and rx herculink were retracted over the guide wire and the herculink was re-advanced over the same guide wire without resistance and to the target lesion.The herculink omnilink stent was then deployed at the target site without issue.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4) - use after damage.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

• 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 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3568340
• MDR Text Key: 11521544
• Report Number: 2024168-2014-00194
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 1011528-12
• Device Lot Number: 3072561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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
• Treatment: GUIDE WIRE: 0.014IN. SPARTACORE 300CM