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

Catalog Number	1125275-18
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	08/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however the reported treatments appear to be related to circumstances of the procedure.The reported patient effects of angina and thrombosis are listed in the xience alpine everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.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 the procedure was to treat an eccentric de novo lesion in the proximal left anterior descending artery with mild calcification and 90% stenosis.The patient was taking anti-platelet medication on 2016.The patient was diagnosed with angina and was admitted to the hospital on (b)(6) 2016.After performing pre-dilatation with an unspecified balloon, a 2.75x18mm xience alpine rx stent delivery system (sds) was advanced toward the target lesion, the system was inflated up to 14 atmospheres and the stent was implanted.Post-dilatation was performed per standard procedure.No thrombosis was observed prior to or during the procedure.On (b)(6) 2016 while in the hospital, the patient complained of angina.Angiography was performed and the stent was found to be occluded with thrombosis.The thrombosis was treated via angioplasty.It was confirmed that the patient was compliant with dual antiplatelet therapy (dapt).There was no reported adverse patient sequela 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: 5873002
• Report Number: 2024168-2016-05374
• Device Sequence Number: 13773352
• Product Code: NIQ
• UDI-Device Identifier: 08717648199264
• UDI-Public: (01)08717648199264(17)190208(10)6012261
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2016

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: 02/08/2019
• Device Catalogue Number: 1125275-18
• Device Lot Number: 6012261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2016
• Initial Report FDA Received Date: 08/12/2016
• 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: Required Intervention
• Patient Age: 66 YR