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

Catalog Number 1011344-40

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported tip detachment.The emboshield nav6 referenced is being filed under a separate medwatch report.

Event Description

It was reported that the procedure was to treat a lesion located in the heavily calcified, left carotid artery.An emboshield nav6 protection device was placed followed by pre-dilatation with a 4.0 x 20 viatrac balloon catheter.The 7-10/40 acculink ii stent delivery system (sds) was advanced without resistance felt and deployed successfully.No resistance was felt during retraction of the sds and the stent implant was post-dilated with a 5 x 40 mm viatrac balloon.The retrieval catheter for the filter was advanced to capture the filter; however, it appeared that there was something preventing the filter from being captured.Further investigation revealed that the tip of the stent delivery system had separated and was located on the barewire and that this is what was preventing capture of the filter.The wire was pulled on hard and the filter was able to be captured and removed from the patient without further issue.Outside the patient it was confirmed that the tip of the stent delivery system had separated and was on the wire.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

• 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 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: 5894585
• MDR Text Key: 52724313
• Report Number: 2024168-2016-05583
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: (01)08717648076398(17)180430(10)6050561
• 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: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 1011344-40
• Device Lot Number: 6050561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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: 90 YR
• Patient Weight: 58