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

Catalog Number 1011493-18

Device Problems Unstable (1667); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the right renal artery.A 5.0x18mm herculink stent delivery system (sds) was advanced and had difficulty navigating a turn in the patient anatomy.The sds was withdrawn to perform additional pre-dilatation, and the stent was noted to have shifted on the balloon.A new 5.0x15mm herculink sds was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation and the reported stent movement was not confirmed.The reported failure to advance could not be confirmed as it was based on case circumstances.Based on visual and dimensional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that the reported failure to advance and stent damage is related to case circumstances.A review of the lot history record revealed no non-conformances.A query of the electronic complaint handling database revealed no other incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 5391612
• MDR Text Key: 36939339
• Report Number: 2024168-2016-00445
• Device Sequence Number: 1
• Product Code: NIN
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 1011493-18
• Device Lot Number: 5072161
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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