MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; 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	Myocardial Infarction (1969); Stenosis (2263)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient id: (b)(6).It was reported through the tactics registry that a 4x23mm xience sierra drug eluting stent (des) was implanted in the mid right coronary artery (rca) on (b)(6) 2020.Dual antiplatelet treatment was given after stent implantation on (b)(6) 2021 the patient experienced a myocardial infarction and 100% stenosis was noted proximal to the xience sierra stent.A non-abbott stent was implanted from the new lesion overlapping into the implanted xience sierra stent, and a drug coated balloon was used as well.On (b)(6) 2021, the patient recovered and was discharged from the hospital.It is the physician¿s opinion that the event was not related to the study as it was progression of disease.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 stenosis and myocardial infarction are listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) 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; 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.

• 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: 15765117
• Report Number: 2024168-2022-11456
• Device Sequence Number: 6238984
• Product Code: NIQ
• UDI-Device Identifier: 08717648227516
• UDI-Public: 08717648227516
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2022

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: 1550400-23
• Device Catalogue Number: 1550400-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 11/09/2022
• 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: Required Intervention; Hospitalization; Disability
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 48 KG