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

Catalog Number 1070300-33

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

Patient Problems Angina (1710); Pseudoaneurysm (2605)

Event Date 04/13/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated dates.The device was not returned for evaluation.A review of the lot history record of the reported device could not be conducted because the lot number was not provided.The reported patient effects of pseudoaneurysm and angina is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use 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.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.The 2.5x18 mm xience xpedition stent referenced is filed under a separate medwatch report number.Literature attachment.Article title: a case report of a coronary artery aneurysm as a rare complication of percutaneous coronary intervention.

Event Description

It was reported in a research article that the procedure was to treat multi-vessel disease.For treatment of the mid left anterior descending (lad), pre-dilatation was performed and a 3.0x33 mm xience xpedition stent was implanted at the proximal part.Because of residual stenosis in the mid part, another 2.5x18 mm xience xpedition stent was implanted.The patient was discharged in good condition.Six weeks later, the patient experienced chest pain and angiography showed a pseudoaneurysm in the mid portion of the lad at the site of the previous stenting.Bypass graft surgery was performed to resolve the pseudoaneurysm and treat the patient's coronary artery disease.No additional information was provided.For full details, see attached article titled: "a case report of a coronary artery aneurysm as a rare complication of percutaneous coronary intervention.".

• Brand Name: XIENCE XPEDITION 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: 11394264
• MDR Text Key: 234215319
• Report Number: 2024168-2021-01560
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1070300-33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 60 YR