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

Catalog Number 1070250-28

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

Patient Problems Angina (1710); High Blood Pressure/ Hypertension (1908); Stenosis (2263)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina, stenosis and hypertension are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that on (b)(6) 2015, a 2.5x33 mm and a 2.5x28mm xience xpedition stent were successfully implanted in the left anterior descending artery that was 90% stenosed.The patient was discharged on (b)(6) 2015.On (b)(6) 2019, the patient was re-hospitalized for intermittent chest tightness.Chest pain worsened for a period of 10 days, which was then diagnosed as coronary heart disease, hypertension, and hyperlipidemia.The patient was given antiplatelet aggregation and lipid-lowering medications.The patient also had a decrease in myocardial oxygen consumption.The patient was given anti-hypertensive medication to improve myocardial metabolism, micro circulation, and also received other comprehensive therapy.The patient underwent angiography on (b)(6) 2019, which showed there was no obvious stenosis in the left trunk, multiple plaques in the anterior descending artery, severe intimal hyperplasia in the stent about 60-70% stenosis, and multiple plaques in the cyclotron artery, 40-50% stenosis.The right coronary artery is fine with 50-60% stenosis.The patient recovered well.The patient had no chest tightness, chest pain or other discomfort.On (b)(6) 2019, the patient was discharged home.Per the physician, the event was not related to the device.No additional information was provided.

• 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: 10326908
• MDR Text Key: 200799290
• Report Number: 2024168-2020-06208
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 07/27/2020

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: 08/12/2016
• Device Catalogue Number: 1070250-28
• Device Lot Number: 4080641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 79