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

Catalog Number	1125250-08
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/29/2016
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: stent: 2.5x23 mm xience alpine, 3.0x12 mm xience alpine.The device was not returned for evaluation.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, could not be determined; however, the reported treatments appear to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.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 on (b)(6) 2016 a 2.5x8 mm xience alpine stent, a 2.5x23 mm xience alpine stent and a 3.0x12 mm xience alpine stent were implanted in an unspecified coronary artery.On (b)(6) 2016, the patient was re-admitted for other cardiovascular symptoms, gastrointestinal bleed, unspecified treatment was performed.The final patient outcome was reported as unknown; however, the patient was discharged to 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: 5975495
• Report Number: 2024168-2016-06393
• Device Sequence Number: 316068
• Product Code: NIQ
• UDI-Device Identifier: 08717648199141
• UDI-Public: (01)08717648199141(17)180907(10)5090141
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2016

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 Expiration Date: 09/07/2018
• Device Catalogue Number: 1125250-08
• Device Lot Number: 5090141
• 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: 09/23/2016
• 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: 55 YR
• Patient Weight: 117