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

Catalog Number	1007849-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2016
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 and dimensional inspection was performed on the returned device.The reported detachment of the device (shaft separation) was confirmed.The reported failure to advance 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 that the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during the procedure to treat a very heavily calcified lesion in a non-tortuous saphenous vein graft (svg) to the circumflex (cx) coronary artery, an attempt to cross was made with a 3.5x28 rx vision bare metal stent (bms) system, but this device failed to cross due to patient anatomy and the proximal shaft separated into two pieces (approximately 10cm distal to the strain relief).The distal portion was able to simply be withdrawn from the anatomy without difficulty.An attempt to cross was then made with a 5.0x20 nc trek rx balloon dilatation catheter (bdc), but this device also failed to cross due to patient anatomy and the shaft became bent (kinked) and was withdrawn.A 4.0x12 non-abbott stent was able to cross and treat the lesion successfully.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

• Brand Name: MULTI-LINK RX VISION 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: 6192090
• Report Number: 2024168-2016-09092
• Device Sequence Number: 415522
• Product Code: MAF
• UDI-Device Identifier: 08717648050732
• UDI-Public: (01)08717648050732(17)181231(10)6011341
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/20/2016

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 Expiration Date: 12/31/2018
• Device Catalogue Number: 1007849-28
• Device Lot Number: 6011341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR