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

Catalog Number	1007821-08
Health Effect - Clinical Codes	Angina (1710); High Blood Pressure/ Hypertension (1908); Occlusion (1984)
Date of Event	03/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).There was no reported device malfunction and the product was not returned as it remains implanted.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 angina and occlusion as listed in the multi-link vision coronary stent systems (css), instructions for use are known patient effects that may be associated with use of a coronary stent in native coronary arteries.A conclusive cause for the reported patient effects and the relationship to the product, if any, could not be determined.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 in 2016, a mini vision stent was implanted in the coronary artery.On (b)(6) 2018, the patient was hospitalized for chest pain and elevated blood sugars.On (b)(6) 2018, an angiogram was performed.The previously implanted stent was treated and another stent was implanted.The event resolved and the patient was discharged.There was no additional information 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: 7367928
• Report Number: 2024168-2018-02152
• Device Sequence Number: 37526
• Product Code: MAF
• UDI-Device Identifier: 08717648049378
• UDI-Public: 08717648049378
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 1007821-08
• Device Lot Number: 5070341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/23/2018
• 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
• Patient Age: 85 YR
• Patient Weight: 56