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

Catalog Number 1011341-40

Device Problems Positioning Failure (1158); Physical Resistance (2578); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a de novo lesion located in the very narrow, heavily calcified and highly tortuous distal internal carotid artery.Due to the anatomy, it took a long time to get the acculink rx 9/40 stent delivery system (sds) to the lesion; however, it was able to cross, but barely.An attempt was made to deploy the stent; however, it would not deploy due the difficulty with the sds handle.Several more attempts were made to deploy the stent; however, these failed so the acculink sds was retracted from the patient.A new accculink rx 9/40 was used, was able to enter through the sheath smoothly and was deployed successfully.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.Returned device analysis revealed a tear in the shaft of the delivery system.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The difficulty deploying the stent was not able to be confirmed.The reported resistance could not be confirmed as it was based on case circumstances.The inner member was torn 2 cm distal to the guide wire exit notch for a length of 1 mm.Based on a visual, dimensional, and functional 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 similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.

• 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: 4310569
• MDR Text Key: 5135333
• Report Number: 2024168-2014-08049
• 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
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 1011341-40
• Device Lot Number: 3061261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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