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

Model Number	1550350-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Myocardial Infarction (1969)
Date of Event	03/02/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2020, the patient presented with a severely calcified proximal circumflex (cx) coronary artery lesion.Pre-dilatation and atherectomy was performed.A 3.5x28mm xience sierra stent (1550350-28, 9110641) was implanted without complications.Stent placement was reportedly acceptable with 0% diameter stenosis and timi flow iii.On (b)(6) 2020, the patient passed away due to a myocardial infarction (mi).No additional information was provided regarding this issue.
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.It should be noted that the reported patient effect(s) of myocardial infarction and death are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect(s) 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.
Event or Problem Description
Subsequent to the initial report filed, additional information received: the physician assessed the death as having an unknown relationship to the device.

• 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: 9935499
• Report Number: 2024168-2020-03473
• Device Sequence Number: 11442484
• Product Code: NIQ
• UDI-Device Identifier: 08717648227448
• UDI-Public: 08717648227448
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 11/13/2020
• Device Model Number: 1550350-28
• Device Catalogue Number: 1550350-28
• Device Lot Number: 9110641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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: Death
• Patient Age: 65 YR
• Patient Weight: 69