MAUDE Adverse Event Report: AV-TEMECULA-CT MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

Catalog Number	1007821-23
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: a visual and functional inspection was performed on the returned device.The reported device causing damage to another device was confirmed.The reported failure to advance and difficult to remove could not be tested as it was based on operational circumstances.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat the proximal left anterior descending artery (lad).A non-abbott stent was deployed successfully in the proximal lad.An attempt was made to cross with the 2.0 x 23 mm mini vision sds and during the attempt to cross through the non-abbott stent, the mini vision stent became caught on the deployed non-abbott stent.The devices were removed from the patient as one unit and after removal it was observed that the non-abbott stent was explanted.No adverse patient effects were noted; therefore, the procedure continued on with the successful deployment of non-abbott and abbott stents.No additional information was provided.

• Brand Name: MULTI-LINK MINI VISION RX 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: 6609287
• Report Number: 2024168-2017-04740
• Device Sequence Number: 687558
• Product Code: MAF
• UDI-Device Identifier: 08717648049415
• UDI-Public: (01)08717648049415(17)190430(10)6051841
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2017

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: 04/30/2019
• Device Catalogue Number: 1007821-23
• Device Lot Number: 6051841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR