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

Catalog Number 1011344-40

Device Problems Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation however; it is likely that device interactions during procedure contributed the reported stent migration.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 identified no other similar incidents reported from this lot.The investigation determined the reported difficulties and treatment appears related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The emboshield device referenced in b5 and d11 is filed under a separate medwatch report.

Event Description

It was reported that the procedure was to treat a lesion in the heavily tortuous, heavily calcified internal carotid artery.After placement of the emboshield nav 6 embolic protection system, a 7-10 x 40 mm acculink self-expanding stent system (sess) was advanced without resistance to the lesion; and was successfully deployed.The stent was post-dilated with an unspecified balloon dilatation catheter.During removal of the nav 6 device; when pulling the barewire and the filter resistance was felt with the anatomy, and the deployed acculink stent was pulled into the carotid common artery.No further treatment was performed in the internal carotid artery.The acculink stent remains well apposed in healthy tissue in the common carotid artery.There was no adverse patient sequela and no clinically significant delay during the procedure.

• 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: 6336276
• MDR Text Key: 67597570
• Report Number: 2024168-2017-01260
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: (01)08717648076398(17)180930(10)6100361
• 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,consum
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 1011344-40
• Device Lot Number: 6100361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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 Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 102