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

Catalog Number 1010126-30

Device Problems Positioning Failure (1158); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

It was reported that during treatment of a lesion in the right internal carotid artery.Reportedly, it was not possible to release the stent as excessive resistance was experienced retracting the protective sheath.The device was removed from the patient anatomy and the procedure was completed using an unspecified coronary stent.There were no reported adverse patient sequelae and no reported significant clinical delay in the procedure.No additional information was provided.Returned device analysis noted that the distal end of the stent was exposed.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The difficulty deploying the stent was able to be confirmed.In addition, the distal end of the stent was noted to be exposed.Based on a visual 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 incidents for failure to deploy 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: 3932691
• MDR Text Key: 4530376
• Report Number: 2024168-2014-04500
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 1010126-30
• Device Lot Number: 3071261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2014
• 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