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

Catalog Number	1007821-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)((4).The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation determined that the reported difficulties and subsequent treatments appear to be related to circumstances of the procedure.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.
Event or Problem Description
It was reported that during a procedure of the left anterior descending (lad), due to the acute angle of the vessel, the 2.0 x 8 mm mini-vision stent became dislodged from the balloon and remained on the guide wire.A 1.5 x 8 mm balloon was used to retrieve and remove the stent from the anatomy.The procedure was completed using balloon angioplasty.There was no reported adverse patient effect or a clinically significant delay in the procedure.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: 6087404
• Report Number: 2024168-2016-07717
• Device Sequence Number: 18974962
• Product Code: MAF
• UDI-Device Identifier: 08717648049378
• UDI-Public: (01)08717648049378
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 11/08/2016

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 Catalogue Number: 1007821-08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2016
• Initial Report FDA Received Date: 11/08/2016
• 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: 61 YR