• 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 Unintended Movement (3026)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Atrial Perforation (2511); Pericardial Effusion (3271)
Event Date 05/18/2020
Event Type  Death  
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report unintended movement, pericardial effusion and death. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+. Prior to the procedure, it was noted that the patient presented to the hospital with late presentation myocardial infarction and developed papillary muscle rupture and flail of the posterior leaflet. It was noted that the patient was intubated and placed on intra-aortic balloon pump (iabp) and inotropic support. The physician decided to continue with a mitraclip procedure; therefore, the steerable guide catheter (sgc) was inserted. However, while removing the guide wire, due to tension on the device, the sgc slightly moved forward. It was then noticed that, the patients blood pressure decreased. A pericardial effusion was noted immediately after. Emergency pericardiocentesis was performed; however, no significant reduction of the effusion occurred. The decision was made to open the chest by surgery. A large holed was then noted at the base of the left atrium (la) appendage and was attributed to the insertion of the sgc. The patient then passed away due to the pericardial effusion. There was no clinically significant delay in the procedure. 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 Key10128924
MDR Text Key194343380
Report Number2024168-2020-04786
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUK
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 09/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/24/2021
Device Catalogue NumberSGC0302
Device Lot Number00225U134
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 Received08/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/25/2020
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: 06/08/2020 Patient Sequence Number: 1
-
-