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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 SGC0301
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); Weakness (2145)
Event Date 07/18/2018
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.
 
Event Description
This report is filed due for post procedure femoral vein bleed, hematoma, disseminated vascular coagulation (dic), and death. It was reported that a mitraclip procedure was performed. One mitraclip was implanted in the patient with degenerative mitral regurgitation (mr) grade 4, reducing the mr to grade 2. There were no device issues. Post-procedure, a femoral venous access site bleed was noted. The patient was too weak for surgery; however, the bleeding was controlled with a femostop device. The femostop device stopped the external bleeding. A computerized tomography scan was performed and a hematoma was noted at the access site. Post-procedure, the patient went into disseminated vascular coagulation (dic). On (b)(6) 2018, the patient had cardiopulmonary arrest and expired. No additional information was provided regarding this issue.
 
Manufacturer Narrative
(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. It should be noted that the reported patient effects of death, hemorrhage, weakness, coagulopathy and cardiac arrest, as listed in the mitraclip system instructions for use (ifu) are known possible complications associated with mitraclip procedures. Based on the information reviewed, the reported weakness was due to the hemorrhage and the hemorrhage appears to be related to procedural conditions. The reported cardiac arrest and subsequent death was due to disseminated vascular coagulation (dic). However, a definitive cause for the dic (coagulopathy) cannot be determined as the account reporter is not willing to discuss the event any further. It is possible that the patients frail condition contributed to the coagulopathy; however, this cannot be confirmed. 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 Key7769089
MDR Text Key116629792
Report Number2024168-2018-06142
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/10/2019
Device Catalogue NumberSGC0301
Device Lot Number80410U134
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 Received10/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2018
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: 08/09/2018 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP
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