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

Catalog Number 1011344-30

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation and confirmed the reported difficulties during deployment.A query of the complaint-handling database indicated that no similar events have been received for deployment difficulties from this lot.Although an expanded records review found no non-conforming material reports from this lot, the potential for a product deficiency does exist.Continued assessment of this issue per site operating procedures is being performed.Corrective and preventive actions will addressed per quality system protocol.

Event Description

It was reported that the acculink device was prepared without any issues noted.It was advanced to the lesion without resistance.When positioned at the lesion, the handle was able to be pulled; however, the stent would not deploy.The device was easily retracted with the stent still fully inside the sheath, with no partial stent deployment or exposure.Another of the same size acculink stent was used to complete the procedure.No adverse patient effects were reported.There was no clinically significant delay of procedure reported.No additional information was provided.Returned device analysis noted partial stent exposure.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

• 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: 3787941
• MDR Text Key: 12112888
• Report Number: 2024168-2014-02792
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 1011344-30
• Device Lot Number: 3110561
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 05/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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: 71 YR