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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

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ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR Back to Search Results
Catalog Number UNK CDS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Renal Failure (2041); Foreign Body In Patient (2687); Pericardial Effusion (3271); Embolism/Embolus (4438); Unspecified Tissue Injury (4559)
Event Date 04/01/2018
Event Type  Injury  
Event Description
This research article was a prospective study designed to evaluate aims to investigate the initial experience of the transcatheter edge-to-edge repair (teer) system, including the g4 system, particularly in terms of short-term outcomes in patients with mitral regurgitation (mr).Complications identified in the study included: hospitalization, in-hospital death, mortality at 30 days, single leaflet device attachment (slda), device embolization, leaflet tear, mitral valve surgery, all stroke, pericardial effusion, major bleeding, acute kidney injury, iatrogenic atrial septal defect closure.In conclusion, the ocean-mitral registry has demonstrated the short-term outcomes of teer systems, including the g4 system, in symptomatic patients with primary and secondary mr.The acute procedural success rate in the g2 system was excellent, and that in the g4 system was expected to improve with the multidisciplinary heart valve team approach.Details are listed in the article titled, "short-term outcomes following transcatheter edge-to-edge repair | insights from the ocean-mitral registry".
 
Manufacturer Narrative
B3: date of event is estimated.D4: the udi number is not known as the part and lot numbers were not provided.D6: the implant date is estimated.The additional patient effects of death and malfunctions reported in the article are captured under separate medwatch reports.The device was not returned for analysis.The lot history record (lhr) and similar incident reviews were not performed because no lot information was provided.Based on available information and due to the limited information available from the article, the cause of the reported slda, expulsion, death, renal failure, embolism, foreign body in patient, cerebrovascular accident, hemorrhage, pericardial effusion, and tissue injury were unable to be determined.The reported patient effects of death, embolism, tissue injury, cerebrovascular accident, pericardial effusion, hemorrhage, and renal failure, the reported hospitalization, unexpected medical intervention, and surgical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
 
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Brand Name
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
Type of Device
VALVE REPAIR
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane n
plymouth MN 55442
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key17805106
MDR Text Key324112872
Report Number2135147-2023-04149
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
Report Date 09/24/2023
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 NumberUNK CDS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/06/2023
Initial Date FDA Received09/24/2023
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; Required Intervention; Hospitalization;
Patient Age80 YR
Patient SexMale
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