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

Model Number	1550350-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	01/23/2020
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 angina, myocardial infarction and thrombosis 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 effects, 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 other xience sierra stent referenced is filed under a separate medwatch report number.
Event or Problem Description
Study patient (b)(6).It was reported that on (b)(6) 2019, the patient underwent a coronary procedure to treat a lesion in the proximal right coronary artery (rca).A 3.0 x 38 mm xience sierra and a 3.5 x 38 mm xience sierra stent were implanted in the proximal rca.The patient was discharged to home on (b)(6) 2019.On (b)(6) 2020, the patient presented to the emergency department with chest pain.The patient reported non-compliance with dual anti-platelet therapy (dapt).The patient was then taken to the cardiac catheterization lab and it was noted that the rca was 100% occluded due to thrombus.A revascularization procedure was performed; however, the physician was unable to cross the target vessel with the unspecified guide wire and no intervention was performed.The patient underwent magnetic resonance imaging (mri) to evaluate for possible coronary artery bypass surgery.Mri noted severe left ventricular enlargement; small subendocardial inferior infarct, but all myocardial segments were viable; no significant valve abnormalities; mildly dilated ascending aorta; and normal appearing pericardium.Bypass surgery has not been scheduled.Aspirin and plavix were prescribed.On (b)(6) 2020, the patient presented to the emergency department with unstable angina.Medication was administered.No additional intervention was performed and the patient is pending surgery.No additional information was provided.
Event or Problem Description
Subsequent to the initial 30-day medwatch report, the following information was provided: on (b)(6) 2020, the patient had an episode of unstable angina and on (b)(6) 2020, coronary artery bypass graft (cabg) procedure was performed.On (b)(6) 2020, the event was noted to be resolved.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9741968
• Report Number: 2024168-2020-01704
• Device Sequence Number: 16764960
• Product Code: NIQ
• UDI-Device Identifier: 08717648227462
• UDI-Public: 08717648227462
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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: 08/15/2020
• Device Model Number: 1550350-38
• Device Catalogue Number: 1550350-38
• Device Lot Number: 9081241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.0 X 38 MM XIENCE SIERRA STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 53 YR
• Patient Weight: 107