MAUDE Adverse Event Report: ABBOTT VASCULAR ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM; CORONARY STENT DELIVERY SYSTEM

Model Number	1003382-13
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.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 the procedure was performed to treat a lesion with no calcification and no tortuosity in left main coronary artery.The 5.0 x 13 mm rx ultra 9-cell stent delivery system (sds) was advanced to the target lesion with no issues; however, during an attempt to deploy the stent, the stent did not deploy.The sds was removed without issue.A new sds was used in the procedure successfully.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported activation failure including expansion failures/inflation 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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported activation failure including expansion failures/inflation issue.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.Na.

• Brand Name: ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10707589
• Report Number: 2024168-2020-08743
• Device Sequence Number: 3569781
• Product Code: MAF
• UDI-Device Identifier: 08717648035302
• UDI-Public: 08717648035302
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P970020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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: 04/30/2021
• Device Model Number: 1003382-13
• Device Catalogue Number: 1003382-13
• Device Lot Number: 9052041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR