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

Catalog Number 1010132-40

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide cath: arrow.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a de novo lesion in the internal carotid artery with mild tortuosity, heavy calcification and 99% stenosis.After performing pre-dilatation with an unspecified balloon, a 6-8x40mm acculink self-expanding stent system (sess) was advanced toward the target lesion and the stent was implanted.The stent system was withdrawn from the patient anatomy and resistance was noted with the introducer sheath.It was not known that the stent system tip separated.Per standard procedure, an unspecified balloon was advanced into the introducer sheath to post dilate the implanted stent.However, it was noted that the balloon pushed the separated tip out of the sheath.The tip moved into the internal carotid artery, distal to the stent.A snare was used to successfully withdraw the tip from the patient anatomy.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported difficulties.The additional treatment/removal of the tip was due to case circumstances.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.(b)(4).

• 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: 5778930
• MDR Text Key: 49068392
• Report Number: 2024168-2016-04437
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 1010132-40
• Device Lot Number: 5060961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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