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

Catalog Number	1007823-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance could not be tested as it was based on operational circumstances and the stent delivery system(sds) was not returned.The investigation determined that the reported difficulties appear to be related to circumstances of the procedure.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.It was reported that resistance was felt during advancement of the sds and force was applied.It should be noted that the multi-link vision rapid exchange (rx) and over the wire (otw) coronary stent systems (css), international, instructions for use (ifu) states: should any resistance be felt at any time during lesion access or delivery system removal, the entire guiding catheter and stent system should be removed as a single unit.Failure to follow these steps and / or applying excessive force to the delivery system can potentially result in loss or damage to the stent and / or delivery system components.Based on the information reviewed and analysis of the returned stent, 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 the procedure to treat a very fibrotic and calcified lesion in the saphenous vein graft (svg) to the 1st obtuse marginal (om1) coronary artery, a non-abbott embolic protection device was placed distal to the lesion.Pre-dilatation was then performed with an unspecified 2.0mm trek balloon.A 2.5x15 rx mini vision bare metal stent (bms) system was advanced to the lesion, but the rx mini vision bms was unable to cross the lesion due to patient anatomy, despite applying force.Prior to withdrawing the rx mini vision (due to failure to cross), the embolic protection device was retracted over the vision, however, while retracting the embolic protection device over the mini vision, the mini vision stent was pulled proximally off of the vision delivery system (dislodged); as the stent was located inside of the embolic protection net, all devices were withdrawn as a single unit without issue.Another same size mini vision was used to complete the procedure.There were no adverse patient effects and no occurrence of a clinically significant delay.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: 6129768
• Report Number: 2024168-2016-08368
• Device Sequence Number: 1076013
• Product Code: MAF
• UDI-Device Identifier: 08717648049514
• UDI-Public: (01)08717648049514
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/28/2016

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 Catalogue Number: 1007823-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2016
• Initial Report FDA Received Date: 11/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMBOLIC PROTECTION: SPIDER