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

Model Number	1550400-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Myocardial Infarction (1969)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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 effects of arrhythmia and myocardial infarction are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures.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 of the device.The three additional xience sierra devices will be filed under separate medwatch report numbers.
Event or Problem Description
It was reported that two xience sierra stents (4x12mm and 2.25x12mm) were implanted in the left anterior descending coronary artery (lad) on (b)(6) 2020.The patient was presented with unstable angina and atherosclerotic heart disease before the procedure.On (b)(6) 2020, the patient was re-admitted with anterior non-st elevated myocardial infarction and palpitations.Two more xience sierra stents (2.75x38mm and 3x18mm) were implanted over the previous stents in the lad on (b)(6) 2020.On (b)(6) 2020, the patient was re-admitted with anterior non-st elevated myocardial infarction and palpitations again.Unspecified balloons were used as treatment, and the final patient outcome is unknown.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: 10491573
• Report Number: 2024168-2020-07377
• Device Sequence Number: 2687652
• Product Code: NIQ
• UDI-Device Identifier: 08717648227486
• UDI-Public: 08717648227486
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

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: 11/24/2020
• Device Model Number: 1550400-12
• Device Catalogue Number: 1550400-12
• Device Lot Number: 9111241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/03/2020
• 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: 77 YR
• Patient Weight: 127