• 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 SGC0302
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thrombosis (2100); Atrial Perforation (2511)
Event Date 07/20/2020
Event Type  Injury  
Manufacturer Narrative
The device is not returning for analysis. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report the suspected thrombus. It was reported this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (mr). The left atrium is enlarged, the fossa ovalis is large, and floppy. A slight patency of patent foramen ovale (pfo) was pre-existing. The steerable guide catheter (sgc) was inserted. A 5cm filamentous tissue was noted, connected from around the fossa ovalis. It is suspected the filamentous tissue is a blood clot, but it is unclear. The filamentous tissue disappeared during the procedure; the physician speculated that it may have been dissolved by a thrombus. The activated clotting time (act) was maintained for more than 250 seconds with heparin, which is the usual procedure range. The procedure was continued. Two clips were implanted, reducing mr to 1+. When removing the sgc into the right atrium, a strong left to right shunt was observed. Per the physician, the left to right shunt occurred in the sgc passage portion of the mitraclip device and was caused by the sgc. The atrial septal defect was of normal size and caused no symptoms; thus, no treatment was performed. 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 Key10382337
MDR Text Key202167926
Report Number2024168-2020-06621
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/26/2020
Device Catalogue NumberSGC0302
Device Lot Number90926U237
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 Received09/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2019
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: 08/07/2020 Patient Sequence Number: 1
-
-