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

Model Number	1550250-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.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 of myocardial infarction is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, 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.
Event or Problem Description
It was reported that the patient has a history of non-st elevated myocardial infarction and had a 2.5x18 mm and 2.75x28 mm xience sierra stents implanted on (b)(6) 2021.On (b)(6) 2021 the patient was readmitted to the hospital due to nstemi and was sent to the cath lab; however, nothing was done.Final patient outcome is listed as unknown.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect(s), 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; therefore, no product-related corrective action will be implemented in this case.B5 - describe event or problem - subsequent to filing the combined initial/final report it was identified that additional information received was inadvertently left off of the initial report.The g3 date for this report is 06/14/2023 which is the date the error was identified.
Event or Problem Description
It was reported that the patient has a history of non-st elevated myocardial infarction and had a 2.5x18 mm and 2.75x28 mm xience sierra stents implanted on (b)(6) 2021.On (b)(6) 2021 the patient was readmitted to the hospital due to nstemi and was sent to the cath lab; however, nothing was done.Final patient outcome is listed as unknown.Subsequent to filing the initial report, update to event description: upon readmission only a measure of cardiac pressures was performed.Final patient outcome was fine, patient was discharged to home.

• 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 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12980573
• Report Number: 2024168-2021-11451
• Device Sequence Number: 20031144
• Product Code: NIQ
• UDI-Device Identifier: 08717648227103
• UDI-Public: 08717648227103
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: 05/03/2023
• Device Model Number: 1550250-18
• Device Catalogue Number: 1550250-18
• Device Lot Number: 1042341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.75X28 MM XIENCE SIERRA STENT
• Outcome Attributed to Adverse Event: Hospitalization; Disability
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 117 KG