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

Model Number	1550400-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lot that would have contributed to this event.The reported patient effect of myocardial infarction is listed in electronic instructions for use everolimus eluting coronary stent systems xience sierra ce (ifu) as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.Additionally, treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) the patient presented with non-st elevated myocardial infarction (nstemi).A 4.0x18mm xience sierra drug eluting stent (des) was implanted.On (b)(6) 2020 the patient was re-hospitalized with a nstemi.It is unknown what treatment was performed and what the final patient outcome was.No additional information was provided.

• 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
• MDR Report Key: 11487687
• Report Number: 2024168-2021-02034
• Device Sequence Number: 3678638
• Product Code: NIQ
• UDI-Device Identifier: 08717648227509
• UDI-Public: 08717648227509
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 12/14/2021
• Device Model Number: 1550400-18
• Device Catalogue Number: 1550400-18
• Device Lot Number: 0060441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/15/2021
• 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: Hospitalization; Required Intervention; Disability
• Patient Age: 47 YR
• Patient Weight: 114