MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1550350-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Thrombosis (2100); Ventricular Fibrillation (2130)
Date of Event	05/14/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 death, thrombosis and dyspnea are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures.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 of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a calcified de novo left main (lm) artery.The right coronary artery was also totally occluded.Pre-dilatation was done with a 3.0x15mm non-abbott balloon.A 3.50x15mm xience sierra stent was implanted in the lm.Post-dilatation was done with a 3.5x12mm non-abbott balloon.The intra-aortic balloon pump was removed.After the patient was returned to the ward, the patient's condition deteriorated suddenly as the patient experienced respiratory discomfort and cardiac arrest occurred.It was confirmed via angiography that a thrombotic occlusion occurred where the stent was deployed.Thrombus aspiration and balloon angioplasty were performed to recanalize.Respiratory discomfort, ventricular fibrillation, and cardiac arrest occurred, then the patient died.Per the physician, the thrombosis was not related to the xience sierra stent nor did the xience sierra cause or contribute to the death.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10158294
• Report Number: 2024168-2020-05065
• Device Sequence Number: 16905405
• Product Code: NIQ
• UDI-Device Identifier: 08717648227417
• UDI-Public: 08717648227417
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2020

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: 09/09/2021
• Device Model Number: 1550350-15
• Device Catalogue Number: 1550350-15
• Device Lot Number: 809034A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 06/16/2020
• 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 Weight: 62