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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR MITRACLIP SYSTEM 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 Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Event Date 04/08/2021
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event. Based on the available information, a cause for the reported pericardial effusion could not be determined. The reported cardiac tamponade and hypotension appear to have been cascading events of the reported pericardial effusion. The reported patient effects of pericardial effusion, cardiac tamponade, and hypotension, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures. The reported unexpected medical intervention and required medication were results of case-specific circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling. Na.
 
Event Description
This is being filed to report during the procedure, a pre-existing pericardial effusion worsened requiring medical intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4. The steerable guide catheter (sgc) was advanced without issue and just when the clip delivery system (cds) was coming out of the sgc, a pericardial effusion was noted, and blood pressure dropped. Pericardiocentesis was performed and medication was administered for the blood pressure drop and the patient was stabilized. The procedure was aborted, and procedure rescheduled for another day. No additional information was provided.
 
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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 Key11740121
MDR Text Key247976469
Report Number2024168-2021-03615
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
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/13/2021
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number00711U204
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 Received04/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2020
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: 04/28/2021 Patient Sequence Number: 1
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