MAUDE Adverse Event Report: ABBOTT VASCULAR RX ACCULINK CAROTID STENT SYSTEM

Model Number	1011344-30
Medical Device Problem Codes	Premature Activation (1484); Ambient Temperature Problem (2878)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during device preparation, the acculink self-expanding stent (ses) was found to be exposed.The device was not used.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial medwatch report, the following information was provided: it was reported that during preparation, the.014 acculink self-expanding stent (ses) was removed from the packaging, when it was noted that the temperature indicator was found to be black.The device was not used.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed.The reported temperature indicator issue was 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 identified no other similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported temperature indicator issue.It is possible that the device was stored inadequately during transportation or at the account however this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5: description of event h6: medical device problem code 1484 - removed.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Common Device Name: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11152750
• Report Number: 2024168-2021-00326
• Device Sequence Number: 11732238
• Product Code: NIM
• UDI-Device Identifier: 08717648076381
• UDI-Public: 08717648076381
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P040012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: 12/31/2020
• Device Model Number: 1011344-30
• Device Catalogue Number: 1011344-30
• Device Lot Number: 9011461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1