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

Catalog Number 1011344-40

Device Problems Difficult or Delayed Positioning (1157); Inaccurate Delivery (2339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual inspection was performed on the returned device.The deployment issue, inaccurate delivery and resistance were not able to be confirmed as the stent was not returned.It is likely that the distal sheath was entrapped or bent within the tortuous anatomy causing the noted resistance with the slider and preventing the sheath from retracting to deploy the stent.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 revealed no other similar incidents.The investigation determined that the reported difficulty was 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

It was reported that the procedure was to treat a lesion located in the right internal carotid artery.After predilatation, the rx.014 acculink ii 7-10/40 was advanced with anatomical resistance through the moderately calcified, heavily tortuous groin and aorta prior to successfully crossing the target lesion.During deployment of the acculink stent, it was reported that the handle slider was difficult to pull back for approximately 3/4 of the way and the tactile feel was "spongy".As a result, the deployment was aborted.When the device was removed from the anatomy, it was observed that the stent was fully deployed but only covering 2/3 of the target lesion.A non-abbott device was used to fully cover the target lesion without issue.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-VS; 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: 6341683
• MDR Text Key: 67972770
• Report Number: 2024168-2017-01336
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: (01)08717648076398(17)180430(10)6051761
• 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: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• 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: 6051761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• 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
• Treatment: EMBOLIC PROTECTION: EMBOSHIELD NAV6
• Patient Age: 90 YR