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

Catalog Number	1125300-15
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	12/06/2016
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 medical products: stent: 2.75 x 8 rx xience alpine; 3.0 x 12 rx xience alpine.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.The reported patient effect of thrombosis is listed in the xience alpine everolimus eluting coronary stent system electronic instructions for use, (ifu) as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The two additional xience alpine devices referenced in the report are being filed under separate manufacturer report numbers.
Event or Problem Description
It was reported that on (b)(6) 2016, a 2.75 x 8 rx xience alpine, a 3.0 x 15 rx xience alpine, and a 3.0 x 12 rx xience alpine drug-eluting stent were implanted for treatment of an unspecified coronary vessel.On (b)(6) 2016, the patient was rehospitalized due to other unspecified cardiovascular symptoms, including thrombosis.Medical intervention was performed via angioplasty and stent placement.The final patient outcome is reportedly unknown.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: 6482414
• Report Number: 2024168-2017-03038
• Device Sequence Number: 850954
• Product Code: NIQ
• UDI-Device Identifier: 08717648199349
• UDI-Public: (01)08717648199349(17)190831(10)6082241
• 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): 04/11/2017

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: 08/31/2019
• Device Catalogue Number: 1125300-15
• Device Lot Number: 6082241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 04/11/2017
• 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: 63 YR
• Patient Weight: 79