MAUDE Adverse Event Report: AV-TEMECULA-CT RX ACCULINK CAROTID STENT SYSTEM

Catalog Number 1011343-40

Device Problems Positioning Failure (1158); Kinked (1339); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a de novo lesion located in the eccentric, mildly tortuous, 85% stenosed, distal internal carotid artery.Due to the tortuosity of the vessel it was difficult to advance the 6-8/40 rx acculink ii stent delivery system (sds) across the lesion.After several attempts, the sds finally crossed; however, deployment of the stent failed.The sds was retracted from the anatomy and it was confirmed that the stent was not exposed or flowering.There was a bend/kink observed in the area the stent is located.A new acculink sds was used to complete the case.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.Returned device analysis revealed the stent implant was exposed and the hyptotube was separated.

Manufacturer Narrative

(b)(4) - against resistance.Evaluation summary: the device was returned for analysis.The difficulty deploying the stent was not able to be confirmed due to the condition of the returned device.The resistance was not able to be confirmed as it was based on case circumstances.The reported kink 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.A query of the electronic complaint handling database revealed no other incidents reported for failure to deploy for this lot.Based on the reviewed information, no product deficiency was identified.It should be noted that the rx acculink instruction for use (ifu) states: should unusual resistance be felt at any time during access or delivery system removal, the guiding catheter or sheath and stent system should be removed as a single unit.Applying excessive force to the stent delivery system can potentially result in loss of or damage to the stent and delivery system components.In this case, it could not be determined if advancing against resistance contributed to the reported difficulties.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID 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: 3953590
• MDR Text Key: 16187978
• Report Number: 2024168-2014-04719
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 1011343-40
• Device Lot Number: 3101761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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
• Patient Age: 70 YR
• Patient Weight: 50