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

Catalog Number 1070350-18

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Respiratory Failure (2484); Thrombosis/Thrombus (4440)

Event Date 02/10/2021

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.Additionally, a review of the complaint history identified no other similar incidents from this lot.The reported patient effects of thrombosis and hypotension are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary procedures.As reportedly the stent was seen on the stent delivery system at the time of deployment, it is possible that interaction with the balloon/device during deflation and/or withdrawal resulted in the reported stent dislodgement; however this cannot be confirmed.The investigation determined a conclusive cause for the reported stent dislodgement cannot be determined.Additionally, the reported stent dislodgement possibly contributed to the reported patient effects; however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatments appear 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

It was reported that the patient presented critically with acute coronary syndrome and an anterior wall myocardial infarction.During treatment of a mildly calcified, moderately tortuous, 80% stenosed, de novo lesion in the proximal left anterior descending(lad) coronary artery, intravascular ultrasound (ivus) noted a plaque rupture.After access to the vessel, a 3.5x18mm xience xpedition drug eluting stent (des) was advanced without issue and deployed; however, during deployment, the patient experienced sudden bradycardia, hypotension and went into cardiac arrest.The delivery system was removed and cardiopulmonary resuscitation (cpr) was successfully performed, reviving the patient.Angiography showed no flow to the lad, no cardiac activity in the left circumflex (lcx) and no stent in the lad or anywhere in the coronary.Cpr was continued, the patient intubated, a temporary pacemaker placed, and emergency medications were given to the patient.Thrombus aspiration was performed.Eventually, the patient was successfully resuscitated.Another 3.5x18mm xience xpedition des was then deployed at the target lesion and post dilated.Ivus showed a well deployed des from the lad to the lmca with no adverse patient sequela.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: 11638795
• MDR Text Key: 245087131
• Report Number: 2024168-2021-02938
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2023
• Device Catalogue Number: 1070350-18
• Device Lot Number: 0022741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention