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

Catalog Number	1007847-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Nausea (1970); Swelling (2091); Diaphoresis (2452)
Date of Event	06/26/2018
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.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.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 2.5 x 23mm multi-link referenced in will be filed under a separate medwatch report number.
Event or Problem Description
On (b)(6) 2018, two rx vision stents (2.75 x 12mm and 2.5 x 28mm) were implanted.Prior to the procedure, the patient was experiencing chest pain.A day after the procedure, the patient was experiencing chest pain, sweats, shortness of breath, nausea and overall not feeling well.Patient went to hospital to check on her allergic reaction and was diagnosed with a bacterial infection in the right lymph node.The physician could not state whether there was a relationship between the stents and the bacterial infection.Patient states that they were allergic to cobalt chromium and was not informed by the physician prior to the procedure that both vision stents contained such metal which caused this allergic reaction to the patient.Patient was provided with an antibiotic.An echocardiogram was performed on (b)(6) 2018 but results were inconclusive.Additionally, patient developed swelling on her left ankle.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: 7719100
• Report Number: 2024168-2018-05746
• Device Sequence Number: 13729947
• Product Code: MAF
• UDI-Device Identifier: 08717648050558
• UDI-Public: 08717648050558
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

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: 07/31/2020
• Device Catalogue Number: 1007847-12
• Device Lot Number: 7081741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: RX VISION (2.5X28)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 75