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

Catalog Number	1007822-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Occlusion (1984); Dizziness (2194)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: stents: rx vision 2.75 x 15 mm; mini vision rx 2.5 x 15 mm; mini vision rx 2.5 x 12 mm.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.Based on the information reviewed, there is no indication of a product quality issue.The reported patient effects of angina, myocardial infarction and occlusion as listed in the multi-link vision rapid exchange (rx) and over the wire (otw) coronary stent systems (css), international, instructions for use (ifu) are known patient effects that may be associated with coronary stenting.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The vision rx and the other two mini vision rx devices referenced are filed under separate medwatch report numbers.
Event or Problem Description
It was reported by the patient that he had a myocardial infarction in the right coronary artery (rca) on (b)(6) 2013.Four vision stents were implanted emergently at (b)(6) by dr.(b)(6).A mini vision rx 2.25 x 8 mm and a vision rx 2.75 x 15 mm were implanted in the mid rca, a mini vision rx 2.5 x 15 mm was implanted in the proximal rca, and a mini vision rx 2.5 x 12 mm was implanted in the distal rca.Four years later, the patient was re-admitted on (b)(6) 2017 with lightheadedness, dizziness, angina and another myocardial infarction.The patient stated he was told that all four of the previously placed stents were 100% blocked; although he was not told whether this was due to thrombosis or re-stenosis.Two additional unknown stents were emergently implanted as treatment at (b)(6) by dr.(b)(6).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: 7843580
• Report Number: 2024168-2018-06854
• Device Sequence Number: 1565285
• Product Code: MAF
• UDI-Device Identifier: 08717648049439
• UDI-Public: 8717648049439
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2013
• Device Catalogue Number: 1007822-08
• Device Lot Number: 0121341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/04/2018
• 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; Disability
• Patient Age: 52 YR
• Patient Weight: 72