MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 30MM X 80MM

Device Problems Break (1069); Entrapment of Device (1212); Unexpected Therapeutic Results (1631)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262); Device Embedded In Tissue or Plaque (3165)

Event Date 02/02/2022

Event Type  Death  

Event Description

"we then repositioned our wire down the lad and performed intravascular ultrasound to the lad showing a probable greater than 70% stenosis. At the time of lad ultrasound the patient became acutely ill with chest pain, some bradycardia and hypotension. Angiogram was performed and there was no flow in our circumflex where we had performed angioplasty. We rewired the circumflex, went back down with a 3. 0 balloon and performed balloon inflations with some improvement in flow. I then went in with a longer 3. 0 x 30 balloon and once again performed balloon inflation. About this time, the patient developed cardiac arrest with bradycardia. He was treated with atropine and epinephrine but unfortunately did not really respond. The long 3. 0 balloon was removed and, at the time of removal, the balloon came off the shaft and became lodged in the proximal circumflex and into the left main. Over the course of 30 minutes we made numerous attempts to retrieve the balloon with a snare with different devices to try to puncture the balloon or sandwich the balloon into the guide for removal, with no success, continued cpr and acls resuscitation was performed and the patient was intubated. An impella was placed in the right groin at our previous angiogram cath site and then access was obtained in the left groin for continued attempts to retrieve the balloon. After a considerable amount of time of cpr resuscitation and no success in balloon retrieval, the procedure was discontinued and the patient was pronounced, overall cause of death is cardiogenic shock from cardiac arrest due to coronary balloon lodging in the left main. ".

• Brand Name: TREK CORONARY DILATION CATHETER
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR; st clara CA
• MDR Report Key: 13548867
• MDR Text Key: 285809034
• Report Number: MW5107513
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 30MM X 80MM
• Device Lot Number: 10330G1
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 02/16/2022 Patient Sequence Number: 1

Treatment

3.0 BALLOON CATHETER; ATROPINE; EPINEPHRINE; IMPELLA; SNARE