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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 SGC0302
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoxia (1918); Perforation (2001); Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446)
Event Date 09/14/2021
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 this event. Based on available information, the cause of reported heart failure was due to atrial perforation. The cause of atrial perforation could not be determined. The cause of reported hypoxia and renal failure could not be determined. The reported patient effects of heart failure, atrial septal defect, respiratory dysfunction and renal failure are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures. The reported hospitalization was a result 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 after the procedure, the patient experienced respiratory distress, heart failure, atrial perforation and renal failure. It was reported that the mitraclip procedure was performed on (b)(6) 2019 to treat functional mitral regurgitation (mr) with grade 4. One clip was implanted, reducing mr to 1. On (b)(6) 2021, the patient had a follow-up and was experiencing respiratory distress. A computerized tomography (ct) scan showed congestion and enlargement of the heart. There was no deterioration [increase] of mr confirmed, the clip remained stable on both leaflets and no tissue damage was noted, but a left to right shunt was confirmed on echocardiography. An increase in brain natriuretic peptide (bnp) level and deterioration of renal function was also observed. Since iatrogenic atrial septal defect is the cause of exacerbation of heart failure, the patient is scheduled for surgery at a later date. 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 Key12590625
MDR Text Key275183953
Report Number2024168-2021-08988
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 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/03/2020
Device Catalogue NumberSGC0302
Device Lot Number90502U110
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 Received10/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2019
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: 10/07/2021 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP
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