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

Catalog Number 1011343-40

Device Problems Detachment Of Device Component (1104); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure to treat a lesion in the left internal carotid artery with no calcification, a 6x8x40 mm rx acculink carotid stent system was prepped and flushed per the instructions for use without any issues noted.The distal mandrel was removed without issue and the stent system was advanced over the guide wire without resistance when it was noted that the stent was exposed from the sheath and the tip became separated.Reportedly, the tip may have become damaged during prep although no damage was noted prior to advancing the stent system onto the guide wire.The stent system was replaced with a new same size acculink carotid stent system to successfully treat the target lesion.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The premature deployment and tip separation were able to be confirmed.Based on a visual 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: 4503520
• MDR Text Key: 5534224
• Report Number: 2024168-2015-00704
• 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
• Report Date: 01/19/2015

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: 10/31/2016
• Device Catalogue Number: 1011343-40
• Device Lot Number: 4110361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2015
• Initial Date FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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: 43 YR