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

MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR

  • 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 VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Catalog Number UNK SGC03
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 03/23/2021
Event Type  Injury  
Manufacturer Narrative
Date estimated. The udi number is not known as the part and lot number were not provided. The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is being filed to report that after a mitraclip procedure, a left to right and right to left shunting at the septum was observed. T was reported that the first mitraclip procedure was performed on (b)(6) 2018 to treat functional mitral regurgitation (mr). Two clips were deployed and the mr grade was reduced. On unknown date, the patient presented with increased mr, with a grade of 3-4 due to progression of disease and bidirectional shunt was noted. There was no tissue damage noted to the leaflets and the clips remained stable on both leaflets. It was thought that the steerable guide catheter (sgc) used in the index procedure had worsened the asd. The clips were confirmed to be attached to both leaflets. On 3/24/2021, an additional clip was implanted reducing mr from 3-4 to 1 and an asd occluder was implanted for treatment. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key11661253
MDR Text Key245344139
Report Number2024168-2021-03094
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
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 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK SGC03
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 Received05/12/2021
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: 04/13/2021 Patient Sequence Number: 1
Treatment
2 IMPLANTED MITRACLIP
-
-