• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012272-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anaphylactic Shock (1703); Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Hypersensitivity/Allergic reaction (1907)
Event Date 03/31/2019
Event Type  Death  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The customer reported the device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The two xience sierra stent systems are filed under separate medwatch reports.
 
Event Description
It was reported that this was a routine percutaneous coronary intervention (pci) procedure in a stable patient who presented with a non-st-elevation myocardial infarction. The patient had a history of previous anaphylaxis to peg-7 (polyethylene glycol). Within minutes of introducing the trek rx balloon dilation catheter, the patient developed bradycardia and hypotensive shock. Two xience sierra stents were rapidly placed in the left anterior descending coronary artery. At some point during the procedure, the patient went into pulseless electrical activity (pea). Resuscitation was unsuccessful, and patient expired. No additional information was provided.
 
Manufacturer Narrative
(b)(4). There was no reported device malfunction and the product was not returned. 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 effect of death is listed in the coronary dilatation catheters (cdc), trek rx global, instruction for use (ifu), as a known patient effect. A conclusive cause for the reported patient effects of bradycardia, cardiac arrest, death, hypersensitivity, and the relationship to the product, if any, cannot be determined. The investigation determined the reported shock appears to be related to a potential product quality issue. The issue is being addressed per internal operating procedures. Abbott vascular will continue to trend the performance of these devices.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key8668880
MDR Text Key147014310
Report Number2024168-2019-04406
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2021
Device Catalogue Number1012272-20
Device Lot Number90118G1
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 Received06/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2019
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: 06/04/2019 Patient Sequence Number: 1
-
-