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

Model Number 1550250-38

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

Patient Problems Angina (1710); Myocardial Infarction (1969); Stenosis (2263)

Event Date 08/04/2021

Event Type  Injury  

Manufacturer Narrative

The age and weight were obtained from the index procedure date.Date of event: estimated date.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.The additional xience device mentioned is being filed under a separate medwatch report number.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2020, the patient presented in with a recent non-st elevated myocardial infarction (nstemi) and a percutaneous intervention was performed on the left anterior descending (lad), 80% stenosed lesion.Pre-dilatation was performed and a 2.5x38mm xience sierra and a 2.5x12mm xience sierra stents were successfully implanted with acceptable results.0% residual stenosis and without complications.On (b)(6) 2021, the patient presented with intermittent left lower parasternal chest discomfort, unstable angina, for approximately one week.Elevated cardiac labs were observed.The patients vital signs and heart failure lab probnp were within normal range.The ekg revealed t wave inversion and st elevation in lead 4 and a non-st elevated myocardial infarction (mi) was diagnosed.The chest x-ray revealed no acute abnormality.Medication was provided.On (b)(6) 2021, a target vessel revascularization was performed, placing another stent in the 99% stenosed lesion.Reportedly, both xience sierra stents had restenosed.There was no device malfunction.The event resolved without sequela.No additional information was provided regarding this issue.

Manufacturer Narrative

A2, a4: the age and weight were obtained from the index procedure date.B3: estimated date.The device was not returned for analysis.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, angina and stenosis are listed in the xience sierra everolimus eluting coronary stent systems 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; however, the subsequent 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.

• 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: 12395861
• MDR Text Key: 271889368
• Report Number: 2024168-2021-07728
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227141
• UDI-Public: 08717648227141
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/24/2021
• Device Model Number: 1550250-38
• Device Catalogue Number: 1550250-38
• Device Lot Number: 0061241
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XIENCE SIERRA STENT
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 58 YR
• Patient Weight: 108