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

Catalog Number	1007822-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported difficult to position (guide wire) and difficult to remove (guide wire) could not be tested due to the condition of the returned device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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.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 a lesion located in the left anterior coronary artery that was mildly calcified.While advancing the mini vision rx 2.25 x 12 mm stent delivery system (sds) over the guide wire outside the body it got stuck on the wire.When pulling the sds back, the stent came off the wire but the balloon remained on the wire.The device was replaced with another mini vision rx to successfully complete the procedure.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date received by manufacturer inadvertently filed as 03/01/2017; however, the correct date is 3/29/2017.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Subsequent, to the previously filed medwatch report, additional information was received which identified the guide wire noted in the initial case details as a whisper guide wire.

• 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: 6370749
• Report Number: 2024168-2017-01694
• Device Sequence Number: 13710945
• Product Code: MAF
• UDI-Device Identifier: 08717648049446
• UDI-Public: (01)08717648049446(17)190731(10)6080241
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2017

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: 07/31/2019
• Device Catalogue Number: 1007822-12
• Device Lot Number: 6080241
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 04/24/2017; 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1