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

Catalog Number 1011344-40

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation and the reported partial deployment was confirmed.A query of the complaint-handling database indicated that a few 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 procedure was to treat a lesion in the right carotid artery.The 7-10/40 acculink self expanding stent system (sess) was advanced to the lesion without issue.When the stent was attempted to be deployed, the slide would not pull back.The sess was removed.No portion of the stent was exposed.A new acculink sess (7-10/30) was used successfully.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Returned device analysis revealed that the distal sheath was returned retracted 6mm proximal to the tip and 3mm of the stent implant was exposed.The exposed struts were not expanded.

Manufacturer Narrative

(b)(4).The device has been received.Investigation is not yet complete.A follow-up report will be submitted with all relevant additional 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: 3575229
• MDR Text Key: 11577117
• Report Number: 2024168-2014-00303
• 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: 11/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 1011344-40
• Device Lot Number: 3091761
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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