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

Catalog Number	1007823-23
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	10/10/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of myocardial infarction and thrombosis are listed in the multi link vision coronary stent systems electronic instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and 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 on (b)(6) 2012, three multi-link vision stents were implanted.Two stents (3.0x18mm, 3.5x18mm) were implanted in the right coronary artery (rca) and a 2.5x23mm stent was implanted in the mid left anterior descending coronary artery (lad).The patient had not had his new medications filled yet, when eight days after the stent procedure, on (b)(6) 2012, the patient had a myocardial infarction with chest pain when putting up dry wall.The lad was 100% occluded with thrombus and there was moderate disease in the rca, but the rca stents were patent.There was also 80% occlusion in the obtuse marginal artery (om) and 70% occlusion in the posterior descending coronary artery (pda).Coronary artery bypass graft was performed in the lad, oms, and pda.The patient was discharged from the hospital on (b)(6) 2012.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: 6573479
• Report Number: 2024168-2017-04223
• Device Sequence Number: 16276927
• Product Code: MAF
• UDI-Device Identifier: 08717648049538
• UDI-Public: (01)08717648049538(17)150131(10)2022341
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 1007823-23
• Device Lot Number: 2022341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 05/17/2017
• 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: Hospitalization; Required Intervention; Disability
• Patient Age: 63 YR
• Patient Weight: 91