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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
Catalog Number UNK SGC01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Thrombosis (2100)
Event Date 01/14/2012
Event Type  Death  
Manufacturer Narrative
Date of event: dates are estimated. (udi#): in the absence of a reported part number, the udi cannot be calculated. The device was not returned for analysis. A review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided. Based on the available information, a cause for the reported thrombosis and death could not be determined. The reported patient effects of thrombosis and death as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures. The reported treatment with medication(s) and hospitalization were results of case-specific circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report death and thrombus it was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with an unknown grade. It was noted that the patient was obese and had severe pulmonary disease and chronic renal failure. Two clips were successfully implanted. 13 days after the clips were implanted, thrombus was noticed superficial femoral vein in the vascular access site and was treated with medication. However, the patient passed away. Details are listed in the attached article, titled ¿hemodynamic patterns of residual interatrial communication after transcatheter mitraclip repair. ¿ 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 Key11207962
MDR Text Key227986916
Report Number2024168-2021-00578
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K112239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK SGC01
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 Received05/14/2021
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: 01/21/2021 Patient Sequence Number: 1
Treatment
IMPLANTED MITRACLIP
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