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

Model Number	1550400-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Myocardial Infarction (1969)
Date of Event	12/30/2019
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 effect(s) of myocardial infarction, cardiac arrest, and death are listed in the xience sierra everolimus eluting coronary stent systems instructions for use of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient had cardiac arrest twice while being transported to the hospital.Once at the hospital, a percutaneous coronary intervention (pci) was performed that day.A 4.0x23mm xience sierra stent was implanted in an unspecified coronary artery, without reported issues.Reportedly, post-procedure, the patient was doing fine.On (b)(6) 2019, the patient was discharged from the hospital with prescribed brilinta.Reportedly, the physician stated dyspnea was part of the medication (brilinta) side effects.The patient had dyspnea after discharge but assumed it was a medication side effect.Hours after returning home, the patient had a myocardial infarction and went into cardiopulmonary arrest three times.Emergency personnel were called.Cardiopulmonary resuscitation (cpr) was performed and medications provided.The patient expired that day.No autopsy was performed.No additional information was provided regarding this issue.

• 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: 9616369
• Report Number: 2024168-2020-00825
• Device Sequence Number: 503801
• Product Code: NIQ
• UDI-Device Identifier: 08717648227516
• UDI-Public: 08717648227516
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

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: 08/14/2020
• Device Model Number: 1550400-23
• Device Catalogue Number: 1550400-23
• Device Lot Number: 9080741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/22/2020
• 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 Age: 70 YR
• Patient Weight: 88