MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM UNK CDS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-31 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM UNK CDS manufactured by Abbott Vascular.

Event Text Entries

[188868673] Date of event, implant date: estimated dates. The devices are reported from an article; and therefore, will not be requested for return. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The other patient effect reported will be filed under a separate medwatch. (b)(4). Literature: outcomes of ttvi in patients with pacemaker or defibrillator leads data from the trivalve registry.? (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[188868674] This is filed to report pericardial effusion, renal failure,heart failure, cerebrovascular, myocardial infarction, atrial fibrillation, sepsis, prolonged hospitalization, worsening and recurrent tricuspid regurgitation. It was reported through a research article identifying mitraclip devices that may be related to the following: death, pericardial effusion, renal failure,heart failure, cerebrovascular, myocardial infarction, atrial fibrillation, sepsis, prolonged hospitalization, worsening and recurrent tricuspid regurgitation. Specific patient information is documented as unknown. Details are listed in the article, titled outcomes of ttvi in patients with pacemaker or defibrillator leads data from the trivalve registry.?
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03143
MDR Report Key9904611
Report SourceLITERATURE
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2015-01-01
Date Mfgr Received2020-03-10
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, REG # 3005070406
Manufacturer Street3885 BOHANNON DRIVE
Manufacturer CityMENLO PARK CA 94025
Manufacturer CountryUS
Manufacturer Postal Code94025
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMITRACLIP? SYSTEM CLIP DELIVERY SYSTEM
Generic NameVALVE REPAIR
Product CodeNKM
Date Received2020-03-31
Catalog NumberUNK CDS
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Deathisabilit 2020-03-31

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