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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

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ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES Back to Search Results
Catalog Number CDS0705-NT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Angina (1710); Ischemia (1942); Nausea (1970)
Event Date 05/13/2021
Event Type  Injury  
Manufacturer Narrative
The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Date of event is estimated.Date of implant is estimated.Article titled ¿takotsubo syndrome after transcatheter mitral valve repair.¿.
 
Event Description
This is filed to report air embolism.It was reported through a research article that an (b)(6)-old patient present with severe mitral regurgitation (mr) and underwent a transcatheter mitral valve repair (tmvr).It was noted the patient presented with posterior leaflet prolapse and atrial fibrillation.One nt clip was successfully placed on the mitral valve.However, roughly four hours after the procedure, the patient developed sudden nausea, chest distress and ischemia.It was suspected the patient effects may have caused by a coronary air embolism, but that was unable to be confirmed.However, based on the international takotsubo registry criteria, it was confirmed the patient had takotsubo syndrome (tts).The article concluded by stating it was suspected the patients physiological stress was the main cause of the tts.Additional details are listed in the article, titled ¿takotsubo syndrome after transcatheter mitral valve repair.¿ no additional information was provided.
 
Manufacturer Narrative
The product was not returned for analysis.The lot history record review and similar complaint review were not performed because this incident was based on a review article, and no lot information was provided.Based on the limited information provided, a cause for the reported nausea, angina, ischemia, and air embolism cannot be determined.The reported patient effects of nausea, angina, ischemia, and air embolism are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.
 
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Brand Name
MITRACLIP G4 CLIP DELIVERY SYSTEM
Type of Device
MITRAL VALVE REPAIR DEVICES
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 Key12896849
MDR Text Key281430491
Report Number2024168-2021-10883
Device Sequence Number1
Product Code NKM
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberCDS0705-NT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/08/2021
Initial Date FDA Received11/30/2021
Supplement Dates Manufacturer Received12/09/2021
Supplement Dates FDA Received12/29/2021
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age86 YR
Patient SexFemale
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