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	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The investigation determined the reported difficulties 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 the procedure was to treat a very heavily calcified lesion in the very tortuous mid diagonal coronary artery.A 2.0x8mm mini vision rx bare metal stent (bms) system was advanced, but failed to cross the lesion due to patient anatomy and, though no force was applied, the proximal shaft kinked.The stent system was withdrawn without resistance, but the shaft separated (snapped into two pieces) at the kink area during withdrawal.The lesion was then dilated with a 2.0x8mm non-abbott balloon followed by additional attempts to cross the lesion with other unspecified stent system; no other stent systems were able to cross the lesion due to patient anatomy, so the procedure was aborted.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: 6640767
• Report Number: 2024168-2017-05052
• Device Sequence Number: 849218
• Product Code: MAF
• UDI-Device Identifier: 08717648049378
• UDI-Public: (01)08717648049378(17)200131(10)7022141
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/14/2017

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: 01/31/2020
• Device Catalogue Number: 1007821-08
• Device Lot Number: 7022141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 89