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

Model Number	1550300-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Hypoxia (1918); Myocardial Infarction (1969); Neurological Deficit/Dysfunction (1982); Tachycardia (2095); Stenosis (2263); Heart Failure/Congestive Heart Failure (4446)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent 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 the procedure was performed on (b)(6) 2019, to treat a target lesion in the heavily calcified mid left anterior descending (lad) artery.The 2.75 x 38 mm xience sierra stent was implanted, treating the target lesion.On (b)(6) 2020, the patient began to experience shortness of breath (sob) and presented to the emergency department with sob, tachycardia, hypoxia and altered mental status.The patient was placed on bilevel positive airway pressure (bipap), and the patient¿s condition improved with oxygenation.Electrocardiogram noted changes and troponin levels were elevated.In-stent restenosis of 90% was noted in the proximal lad.The patient was admitted to the cath lab with st elevation myocardial infarction equivalent.Two drug eluting stents were implanted in the proximal lad, and three additional drug eluting stents were implanted in the proximal to mid right coronary artery (rca).No additional information was provided.
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 stenosis and myocardial infarction are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a 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.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Additional Manufacturer Narrative
A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
Event or Problem Description
Subsequent to the final mdr, additional information was provided.The patient was re-hospitalized with elevated right heart pressure with significant volume overload [heart failure].The patient was placed on bilevel positive airway pressure (bipap), and the patient¿s condition improved with oxygenation, and later weaned to room air.Intervention was performed to treat restenosis in the left anterior descending artery and the patient condition resolved on (b)(6) 2020.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: 10744358
• Report Number: 2024168-2020-08947
• Device Sequence Number: 16895695
• Product Code: NIQ
• UDI-Device Identifier: 08717648227301
• UDI-Public: 08717648227301
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2021

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: 02/17/2020
• Device Model Number: 1550300-38
• Device Catalogue Number: 1550275-38
• Device Lot Number: 9021141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2020
• Supplement Date Received by Manufacturer: 11/13/2020; 04/12/2021
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 12/04/2020; 04/29/2021
• 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: 29 YR
• Patient Weight: 61