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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

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AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER Back to Search Results
Catalog Number SGC0302
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); High Blood Pressure/ Hypertension (1908); Respiratory Failure (2484)
Event Date 04/11/2019
Event Type  Death  
Manufacturer Narrative
(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. The clip delivery system referenced is filed under a separate medwatch report.
 
Event Description
This is conservatively filed to report possible embolism, resulting in death. It was reported that the initial mitraclip procedure was performed on (b)(6) 2018, to treat functional mitral regurgitation (mr) with a grade of 3-4. A mitraclip was successfully implanted, reducing mr to 1. On (b)(6) 2018, it was noted the clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment (slda)) and the mr increased to 3-4. A second intervention was performed on (b)(6) 2019 in an attempt to treat the slda. After the transseptal puncture, the steerable guide catheter (sgc) was advanced to the left ventricle when the patient became unstable. Cardiopulmonary resuscitation was performed however the patient died due to hypoxia. The physician believed an embolism may have occurred but was not confirmed. No additional information was provided.
 
Manufacturer Narrative
Internal file number - (b)(4). The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. The reported patient effects of death, hypertension, respiratory failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures. The cause for potential embolism, hypertension, respiratory failure and death is unknown. Although a conclusive cause for the reported patient effect(s), and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceSTEERABLE GUIDE CATHETER
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 Key8558269
MDR Text Key143368653
Report Number2024168-2019-03353
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/26/2019
Device Catalogue NumberSGC0302
Device Lot Number80925U239
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 Received06/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2018
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: 04/26/2019 Patient Sequence Number: 1
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