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

Catalog Number 1500350-33

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

Patient Problems Angina (1710); Ischemia (1942); Stenosis (2263)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

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 stenosis, ischemia and angina 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; 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.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2020, the patient presented with a recent non-st elevated myocardial infarction (nstemi) and a percutaneous coronary intervention was performed.Pre-dilatation was performed on the proximal left anterior descending (lad) coronary artery lesion and two xience sierra stents, a 2.5x33 and 3.5x33mm, were implanted without a device issue reported.Timi flow iii with 0% residual stenosis was observed post-procedure.On (b)(6) 2021, the patient was hospitalized for angina, and positive results for myocardial inducible ischemia.The proximal lad, target lesion involving the 3.5x33mm xience sierra stent had restenosed, treated with another stent.The event resolved and the patient was discharged from the hospital in reported good condition.No additional information was provided regarding this issue.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12745713
• MDR Text Key: 279873655
• Report Number: 2024168-2021-09921
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2023
• Device Catalogue Number: 1500350-33
• Device Lot Number: 0042741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XIENCE SIERRA STENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 75