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

MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM CATHETER, PERCUTANEOUS

  • 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
 

ABBOTT MEDICAL AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM CATHETER, PERCUTANEOUS Back to Search Results
Model Number 9-ATV09F45/80
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/22/2020
Event Type  Malfunction  
Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

 
Event Description

Related manufacturer report number: 2135147-2021-00215. It was reported that on (b)(6) 2020, a 25mm amplatzer pfo occluder was selected for implant. During the implant procedure the patient had a short run of supraventricular tachycardia (svt) after positioning, but before device deployment. Adenosine was administered and the patient returned to normal sinus rhythm. The device was successfully implanted. Post-procedure, the patient had bleeding from the left femoral access site. Pressure and a quickclot dressing were applied resolving the event. The patient was reported as stable. No additional information available regarding this event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ABBOTT MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key11902226
MDR Text Key259268381
Report Number2135147-2021-00216
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK190581
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 06/23/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/28/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9-ATV09F45/80
Device Catalogue Number9-ATV09F45/80
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/17/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 05/28/2021 Patient Sequence Number: 1
-
-