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

Catalog Number	1074250-38
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263)
Date of Event	03/19/2017
Type of Reportable Event	Death
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.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, myocardial infarction, thrombosis, stenosis and death are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a 75% stenosed, mildly tortuous, and mildly calcified eccentric lesion in the mid left anterior descending artery.A 2.5x38mm xience xpedition stent was implanted on (b)(6) 2014.A non-abbott stent was implanted on (b)(6) 2014.No patient issues were noted during a follow-up visit on (b)(6) 2015.The patient was admitted to the hospital on (b)(6) 2017 with acute coronary syndrome and presented with myocardial infarction.Thrombosis was confirmed in the proximal part of the implanted xience xpedition (in-stent).The thrombosis was confirmed through angiography.The cause of thrombosis was a rupture of stenosis in the implanted stent.The aspiration of thrombus was performed and percutaneous cardio pulmonary support was introduced.The patient expired on (b)(6) 2017 due to cardiac arrest.Additionally, the dual antiplatelet therapy was not continued since 12-months of dosing period ended.The reported cause of death was stent thrombosis.No additional 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: 6478424
• Report Number: 2024168-2017-03006
• Device Sequence Number: 10975356
• Product Code: NIQ
• UDI-Device Identifier: 08717648162183
• UDI-Public: (01)08717648162183
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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 Catalogue Number: 1074250-38
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 04/10/2017
• 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: Death
• Patient Age: 49 YR
• Patient Weight: 88