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

Catalog Number 1011344-40

Device Problems Difficult to Remove (1528); Device Damaged by Another Device (2915)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The udi is unknown because the part number and lot number were not provided.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.The investigation determined that the reported difficulties 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.The accunet device referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat the right internal carotid artery that was tortuous.A 190 cm accunet embolic protection system (eps) was used with an unspecified acculink self-expanding stent.The stent was deployed; however, the accunet filter met resistance with the deployed stent during removal.Therefore, the accunet eps was carefully removed as a single unit, and the acculink stent remained undamaged and implanted in the lesion.There were no adverse patient effects.There was a slight delay in the procedure, but it was not clinically significant.No additional information was provided.

Manufacturer Narrative

(b)(4).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 incidents.

Event Description

Subsequent to the final report, additional information was received.During removal of the accunet filter along with the embolic protection system (eps), resistance was felt with the deployed 7-10 mm x 40 mm acculink stent.Therefore, a series of maneuvers were done with the recovery catheter and the patient's head was moved; however, it was still not possible to retrieve the filter with the eps.It was not even possible to push the recovery catheter upwards as the unit was stuck with the stent.The recovery catheter was then tugged and the filter was removed from the anatomy.However, the eps also moved the acculink stent from the lesion to the common carotid artery.As stent was the appropriate size for the artery and remained in place, no further treatment was performed.The stent appeared to be well apposed to the vessel.The patient is stable and had a follow-up on (b)(6) 2018.It is possible that the patient will be re-hospitalized in the future as the lesion restenosed.No additional information was provided.

• Brand Name: 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: 7952679
• MDR Text Key: 123538819
• Report Number: 2024168-2018-07816
• Device Sequence Number: 1
• Product Code: NIM
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 1011344-40
• Device Lot Number: 8061461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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): Other