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

Catalog Number 1500250-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Cardiac Enzyme Elevation (1838); Stenosis (2263)

Event Date 06/11/2021

Event Type  Injury  

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 Description

Patient id: (b)(6).It was reported that on (b)(6)2020 two xience sierra stents were implanted in the proximal left anterior descending (lad) coronary artery, sizes 2.5x23 and 2.5x08 mm.On (b)(6) 2021 the patient reported chest pain during effort and was admitted to the hospital.Another percutaneous coronary intervention (pci) was performed in the non-target right coronary artery lesion.A transcatheter aortic valve replacement (tavi) was also performed.There was no report or indication that the tavi procedure was related to the coronary xience sierra stents.On (b)(6)2021, elevated troponin was observed.Another pci was performed, treating the 80% restenosed, proximal lad 2.5x23mm xience sierra stent (1500250-23, 9093042).The event has resolved without sequela.There was no additional information provided.

Manufacturer Narrative

There was no reported device malfunction and the product was not returned.The xience sierra coronary stent remains implanted in the patient.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lot that would have contributed to this event.The reported patient effects of angina and stenosis are listed in the electronic instructions for use, everolimus eluting coronary stent systems xience sierra 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.Additionally, treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12228115
• MDR Text Key: 263539424
• Report Number: 2024168-2021-06487
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2022
• Device Catalogue Number: 1500250-23
• Device Lot Number: 9093042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2.5X08 MM XIENCE SIERRA; 2.5X08 MM XIENCE SIERRA
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 71