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

Catalog Number 1010132-40

Device Problems Break (1069); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the mildly calcified, narrow, mid internal carotid artery.The 6-8/40 acculink stent delivery system (sds) stent was unable to release the stent due to the handle becoming stuck.Force was used in an attempt to move the handle; however, this caused the handle to break.The device was easily exchanged for a new one.No adverse patient effects or clinically significant delay in the procedure were reported.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspection was performed on the returned device.The deployment issue was unable to be confirmed due to the condition of the returned unit.The hypotube break in the handle and tip detachment were confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific product issue.The investigation was unable to determine a cause for the reported deployment issue.The hypotube break and tip detachment were due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

The returned device analysis revealed the inner member, including the tip, was separated from the device.Follow-up with the account confirmed that when the stent delivery system was removed from the anatomy the inner member and tip separated; however, nothing remains in the patient.No additional information 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: 6513649
• MDR Text Key: 73732809
• Report Number: 2024168-2017-03498
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 1010132-40
• Device Lot Number: 6031861
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 71 YR
• Patient Weight: 52