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

Model Number	1550250-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Cardiac Arrest (1762); Myocardial Infarction (1969); Insufficient Information (4580)
Date of Event	01/18/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported that the procedure in a lesion in an unknown artery.At an unspecified time after stent implantation of a xience stent the patient died.No additional information has been provided.
Additional Manufacturer Narrative
Date of death: estimated.Date of event: estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant: estimated.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Subsequent to the initial medwatch report, the following information was received: it was reported that on (b)(6) 2019, the patient was hospitalized.Angiography noted severe stenosis in the left circumflex artery (lcx) and left anterior descending coronary artery (lad) and the patient was diagnosed with a non st-elevation myocardial infarction.On (b)(6) 2019 a 2.5x15 xience sierra stent was implanted in the lcx and on (b)(6) 2019 a 2.5x23mm xience sierra stent was implanted in the lad.On (b)(6) 2020, the patient experienced chest pain and cardiopulmonary arrest.The patient was readmitted to the hospital and attempted to be resuscitated; however, the patient remained in arrest and died.On (b)(6) 2020, an autopsy was performed and it was noted that the patient experienced a new myocardial infarction in the left coronary artery, which was noted to be the cause of death.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the lot number was not reported and the product was not returned for analysis.The reported patient effects of death, angina and myocardial infarction are listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) as a 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; however, the subsequent 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.B2: date of death b3: date of event.D6a: date of implant.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P031); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14838293
• Report Number: 2024168-2022-06943
• Device Sequence Number: 19428748
• Product Code: NIQ
• UDI-Device Identifier: 08717648227097
• UDI-Public: 08717648227097
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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 Model Number: 1550250-15
• Device Catalogue Number: 1550250-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 65 KG