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

Model Number	1550300-23
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Ischemia (1942); Myocardial Infarction (1969)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
On (b)(6) 2019, the patient had a 3.0x23mm xience sierra implanted in the left anterior descending artery with no issues.On (b)(6) 2020 the patient experienced a heart attack due to blockage from the xience stent becoming separated into different pieces.Some blood flow was coming through, but not a lot.A quadruple bypass was performed on the (b)(6) to treat the heart attack.The separated stent still remains in the patient after the surgery.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
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.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported material separation (stent).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 circumstances of the procedure.The reported patient effects of ischemia and myocardial infarction are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) as known patient effects of coronary stenting procedures 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
• MDR Report Key: 11343518
• Report Number: 2024168-2021-01290
• Device Sequence Number: 14403306
• Product Code: NIQ
• UDI-Device Identifier: 08717648227271
• UDI-Public: 08717648227271
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2020
• Device Model Number: 1550300-23
• Device Catalogue Number: 1550300-23
• Device Lot Number: 9061741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/25/2021
• 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: 35 YR
• Patient Weight: 88