MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number UNK RX XIENCE XPEDITION 48

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

Patient Problems Angina (1710); Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Ischemia (1942); Myocardial Infarction (1969); Occlusion (1984); Thrombosis (2100); Stenosis (2263); Prolapse (2475)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

Age: mean age, sex: majority sex, date of event and implant: estimated date.The udi is unknown because the part number and lot number were not provided.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effect(s) of myocardial infarction, stenosis, thrombosis, occlusion, angina, and ischemia are listed in the xience xpedition 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 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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported through a research article identifying the xience xpedition 48 that may be related to death, restenosis, occlusion, plaque shift, thrombosis, target vessel myocardial infarction (mi), ekg changes, elevated cardiac enzymes, chest pain, ischemia, hospitalization, and revascularization.Details are listed in the attached article, titled: ¿treatment with 48-mm everolimus-eluting stents procedural safety and 12-month patient outcome.¿.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Literature attachment: ¿treatment with 48-mm everolimus-eluting stents procedural safety and 12-month patient outcome.¿.

• Brand Name: XIENCE XPEDITION 48 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: 9857480
• MDR Text Key: 186775903
• Report Number: 2024168-2020-02671
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX XIENCE XPEDITION 48
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 65 YR