• 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 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 STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Model Number SGC0301
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hemorrhage/Bleeding (1888)
Event Date 01/31/2020
Event Type  Death  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Based on the information reviewed, the cause for the reported hemorrhage could not be determined. The reported patient effect of hemorrhage is listed in the mitraclip system instructions for use (ifu) are known possible complications associated with mitraclip procedures. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report that during the procedure, the steerable guide catheter (sgc) could have contributed to bleeding in the femoral artery requiring artery repair. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 with a prolapse. The steerable guiding catheter was inserted and advanced without issue. The clip delivery system (cds) was advanced to the mitral valve and grasping was attempted without issue; however, the patient started bleeding out and the abdomen became enlarged. The clip was deployed without leaflet insertion due to the bleeding emergency. After deployment, it was confirmed that the clip was inserted well in both leaflets and was stable; however, the patient was continued bleeding and mr remained at 4 but better than the initial mr grade. It was informed, that the patient had a stent placed 2 days before and was on a high dose of plavix of 600mg which contributed to the bleeding. Blood transfusion was performed. In the physician's opinion, the sgc could have put pressure on that femoral artery causing the bleed. The patient continued to bleed post procedure and was sent to for artery repair. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTEERABLE 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 Key9744686
MDR Text Key181813478
Report Number2024168-2020-01718
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 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/26/2020
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number90726U102
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 Received02/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2019
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: 02/24/2020 Patient Sequence Number: 1
-
-