MAUDE Adverse Event Report: AV-TEMECULA-CT ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

Catalog Number	1003382-13
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/01/2016
Type of Reportable Event	Serious Injury
Additional 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 analysis.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 did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported failure to advance, stent dislodgement, foreign body in patient and the subsequent treatment appears to be related to circumstances of the procedure.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal left main.A 5.0x13mm ultra stent delivery system was advanced to the lesion; however, it failed to cross due to the anatomy.The device was withdrawn; however, the stent dislodged from the stent delivery system upon removal of the device from the patients anatomy.A balloon catheter was used to deploy the stent in healthy tissue.A 4.5x12mm non-abbott stent was successfully deployed proximal to the ultra stent slightly overlapping the stent.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM
• Common Device Name: CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6183562
• Report Number: 2024168-2016-08998
• Device Sequence Number: 11026244
• Product Code: MAF
• UDI-Device Identifier: 08717648035302
• UDI-Public: (01)08717648035302(17)180430(10)6050541
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 1003382-13
• Device Lot Number: 6050541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2016
• Initial Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR