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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER

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ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012272-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 12/17/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number e2019001. The device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The graftmaster devices referenced are being filed under separate medwatch report numbers.
 
Event Description
On (b)(6) 2019, the patient presented with a right coronary artery (rca) chronic total occlusion, left main, left circumflex, and left anterior descending (lad) coronary artery disease. The lad had an ulcerated proximal plaque, was extremely stenotic, and thrombotic occlusion was observed. Balloon dilatation was performed using a trek rx without noted issues and antiplatelet medication provided. Aspiration thrombectomy was performed and medications provided. Two non-abbott stents (onyx) were implanted in the proximal lad. Balloon dilatation was then performed using a 2. 5x15mm trek rx catheter when a mid-distal lad dissection occurred. As treatment, additional angioplasty and a non-abbott stent (onyx) was implanted. Medications were also provided. Timi flow i was observed and additional balloon dilatation was performed using a non-abbott dilatation catheter (euphora) when a distal lad perforation occurred. Medications were provided. Three graftmaster stent delivery systems (2. 8x26mm, then a 2. 8x16mm, and another 2. 8x26mm) were unable to cross the previously implanted, non-abbott stents to the treatment site. During this procedure, the patient experienced chest pain, became combative, was intubated, and anesthesia provided. The patient had coded (cardiopulmonary arrest). Additional dilatation was performed using multiple balloon catheters. An intra-aorta balloon pump was placed, continuous cardiopulmonary resuscitation was performed, and medications administered. Additional aspiration thrombectomy was performed. Timi flow ii was observed, and the patients condition declined. Once off the iabp, there was no underlying heart rhythm and no blood pressure. The patient had expired that day. No additional information was provided regarding this issue.
 
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Brand NameTREK RX CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9572246
MDR Text Key178346969
Report Number2024168-2020-00535
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1012272-15
Device Catalogue Number1012272-15
Device Lot Number90820G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/09/2020 Patient Sequence Number: 1
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