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); Thrombosis (2100)
Date of Event	03/22/2017
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 instructions for use xience alpine everolimus eluting coronary stent systems 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 manufacture, design or labeling.The additional xience alpine device is being filed under separate medwatch report.
Event or Problem Description
It was reported that the initial procedure that took place on (b)(6) 2017 was to treat a lesion located in the non-tortuous, non-calcified mid left anterior descending artery.Two xience alpine stents (3.0 x 12 mm and 3.0 x 15 mm) were deployed via direct stenting for treatment of the lesion, followed by post-dilatation of the stents.The stents were confirmed to be fully apposed to the vessel wall on angiography.On (b)(6) 2017, the patient was rehospitalized experiencing chest pain.Angiography revealed thrombus in the deployed stents.A balloon catheter was used to treat the thrombosis successfully.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: 6662210
• Report Number: 2024168-2017-05288
• Device Sequence Number: 1882074
• Product Code: NIQ
• UDI-Device Identifier: 08717648199332
• UDI-Public: (01)08717648199332(17)191006(10)6092061
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/22/2017

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: 10/06/2019
• Device Catalogue Number: 1125300-12
• Device Lot Number: 6092061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 06/22/2017
• 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