MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1125250-18
Health Effect - Clinical Code	Heart Failure (2206)
Date of Event	01/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.Based on the case information a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.Based on the information reviewed, 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 a 2.5 x 18 mm xience alpine stent was implanted on (b)(6) 2015.On (b)(6) 2016, the patient was re-admitted with cardiovascular symptoms including heart failure.It is unknown what treatment was performed.The final patient outcome is unknown and the patient was discharged home.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 5996632
• Report Number: 2024168-2016-06622
• Device Sequence Number: 10937276
• Product Code: NIQ
• UDI-Device Identifier: 08717648199172
• UDI-Public: (01)08717648199172
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2016

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 Catalogue Number: 1125250-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2016
• Initial Report FDA Received Date: 10/04/2016
• 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: RESOLUTE (X5)
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 111