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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; MITRACLIP DELIVERY SYSTEM

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AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; MITRACLIP DELIVERY SYSTEM Back to Search Results
Catalog Number CDS0501
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Death (1802); Tissue Damage (2104)
Event Date 01/18/2018
Event Type  Death  
Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
 
Event Description
This is filed to report a chordal rupture and the patient death.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr) with a flail.Leaflet grasping attempts failed, due to the prolapsed leaflet and a chordae rupture was observed.The procedure was aborted, without clip implantation.Surgical intervention was recommended, but the patient declined and wished to die peacefully.On (b)(6) 2018, the patient died from cardiogenic shock secondary to severe mitral regurgitation.No additional information was provided.
 
Manufacturer Narrative
(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported failure to adhere or bond to the leaflets appears to be related to patient morphology/pathology (prolapsed leaflet).The reported death was due to the cardiogenic shock and the shock was secondary to the severe mitral regurgitation (mr).The reported tissue damage appears to be related to procedural circumstances of the failure to adhere or bond to the leaflets.The reported patient effects of death, mitral valve injury (tissue damage), and cardiogenic shock, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.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 NT
Type of Device
MITRACLIP DELIVERY SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
MENLO PARK, CA REG# 3005070406
abbott vascular
26531 ynez rd.
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key7261958
MDR Text Key99762411
Report Number2024168-2018-00994
Device Sequence Number1
Product Code NKM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/04/2018
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? Yes
Device Operator Health Professional
Device Expiration Date10/21/2018
Device Catalogue NumberCDS0501
Device Lot Number71021U167
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/18/2018
Initial Date FDA Received02/09/2018
Supplement Dates Manufacturer Received04/30/2018
Supplement Dates FDA Received05/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2017
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) Death;
Patient Age86 YR
Patient Weight61
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