MAUDE Adverse Event Report: AV-TEMECULA-CT RX ACCUNET EMBOLIC PROTECTION SYSTEM

Catalog Number	1011649-55
Medical Device Problem Codes	Difficult to Remove (1528); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional 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.Visual and dimensional inspections were performed on the returned device.The reported difficulty removing through the deployed stent was unable to be tested.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.The investigation determined that the reported difficulties appear to be 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 acculink stent device referenced is being filed under a separate medwatch report number.
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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 10/25/2018.It is possible that the patient will be re-hospitalized in the future as the lesion restenosed.No additional information was provided.

• Brand Name: RX ACCUNET EMBOLIC PROTECTION SYSTEM
• Common Device Name: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7952676
• Report Number: 2024168-2018-07817
• Device Sequence Number: 11109120
• Product Code: NTE
• UDI-Device Identifier: 08717648085161
• UDI-Public: 08717648085161
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 1011649-55
• Device Lot Number: 8030961
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: ACCULINK; STENT: ACCULINK