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

Catalog Number	1125300-12
Health Effect - Clinical Codes	Angina (1710); Cardiac Enzyme Elevation (1838); Thrombosis (2100)
Date of Event	02/23/2017
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.The device was not returned for evaluation.The reported patient effects of angina and thrombosis are listed in the instructions for use as known patient effects of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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 the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the mildy tortuous, moderately calcified, mid left anterior descending coronary artery.On (b)(6) 2017, the patient was experiencing angina and a 3.0x12 mm xience alpine stent was implanted.The patient did not receive any anticoagulation (plavix) drugs after the procedure or during the night of the procedure.The next morning on (b)(6) 2017 the patient presented with angina and enzyme elevation.Angiography was performed and in-stent thrombosis was confirmed.The patient was treated with an unspecified balloon dilatation catheter.It is the physician's opinion that thrombus is a result of the patient not being given any anticoagulation drugs, and not an issue with the device.There were no adverse patient sequelae and no reported clinically significant delay in the procedure.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: 6403835
• Report Number: 2024168-2017-02117
• Device Sequence Number: 663228
• Product Code: NIQ
• UDI-Device Identifier: 08717648199332
• UDI-Public: (01)08717648199332(17)190614(10)6060741
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2017

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: 06/14/2019
• Device Catalogue Number: 1125300-12
• Device Lot Number: 6060741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2017
• Initial Report FDA Received Date: 03/14/2017
• 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: Required Intervention