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	07/05/2017
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.Evaluation summary: a visual inspection was performed on the returned device.The reported stent dislodgement and material deformation 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 identified no other incidents.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.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 heavily calcified lesion in a mid diagonal coronary artery.After performing atherectomy in the lesion, the lesion was pre-dilated with a 2.0 x 20 mm mini trek balloon.An attempt was then made to cross the lesion with a 2.5 x 15 mm mini vision rx bare metal stent (bms) system, with no unusual force applied, but this device failed to cross the lesion.The mini vision rx bms was withdrawn without resistance, however, upon withdrawal, the stent was noted to have dislodged proximally onto the shaft and the proximal end of the stent struts appeared to be mangled.The patient was treated via additional balloon dilatation with an unspecified 2.5 x 8 mm balloon, followed by deployment of a 2.5 x 20 mm non-abbott stent.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: 6736309
• Report Number: 2024168-2017-06155
• Device Sequence Number: 13770060
• Product Code: MAF
• UDI-Device Identifier: 08717648049514
• UDI-Public: 08717648049514
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/24/2017

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: 02/29/2020
• Device Catalogue Number: 1007823-15
• Device Lot Number: 7031041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR