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

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The udi is unknown because the part number and lot number was not provided.It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.The reported difficulties appear to be due to inadvertent user error.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the reviewed information, no product deficiency was identified.Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture or labeling.The accunet filter device referenced is being filed under a separate manufacturing report number.

Event Description

It was reported that the procedure was to treat the carotid artery.After placement of the accunet filter in the vessel, a buddy wire was advanced.The acculink stent delivery system was advanced over the buddy wire instead of the filter wire in error, resulting in the stent being deployed over the filter wire.This caused the filter wire and filter to be wedged behind the stent.During retraction of the open filter from the anatomy, the deployed acculink stent implant became damaged.The patient was sent to surgery for removal of the damaged stent.No additional information was provided.

• Brand Name: ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5234528
• MDR Text Key: 31567666
• Report Number: 2024168-2015-07000
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention