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

Catalog Number	1074225-18
Health Effect - Clinical Codes	Intimal Dissection (1333); Non specific EKG/ECG Changes (1817); Thrombosis (2100)
Date of Event	10/25/2016
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.The reported patient effects of dissection and thrombosis are listed in the xience xpedition everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.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.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 a mildly tortuous, moderately calcified de novo lesion in the proximal right coronary artery (rca).Two xience xpedition drug eluting stents were implanted.The patient was brought back to the lab the same day due to st elevation and angiography confirmed thrombosis in the proximal 2.25x18mm xience xpedition stent.The thrombosis was treated with a non-abbott catheter and intracoronary reopro.The patient was a non-responder for plavix and was not on aspirin at the time of the thrombosis.It is possible there was a mechanical edge dissection.The proximal stent was post-dilated and a larger stent was placed proximal with good results.The patient will be on ticagrelor for 12 months followed by ticagrelor and warfarin for 6 months and finally aspirin and warfarin thereafter.There was no clinically significant delay in the procedure.No additionally information was provided.

• Brand Name: XIENCE XPEDITION 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: 6096177
• Report Number: 2024168-2016-07895
• Device Sequence Number: 16215253
• Product Code: NIQ
• UDI-Device Identifier: 08717648162046
• UDI-Public: (01)08717648162046(17)190710(10)6070441
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2016

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: 07/10/2019
• Device Catalogue Number: 1074225-18
• Device Lot Number: 6070441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 11/11/2016
• 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: 78 YR
• Patient Weight: 95