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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 Fistula (1862); Pain (1994); Thrombosis (2100); Pseudoaneurysm (2605)
Event Date 11/12/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is not returning. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
This report is filed as a pseudoaneurysm occurred post procedure, requiring treatment. It was reported that on (b)(6) 2018, a mitraclip procedure was performed for mitral regurgitation (mr) greater than or equal to 3+. One mitraclip was implanted, reducing the mr to grade 1+. There was no device malfunction. On (b)(6) 2018, the patient experienced right groin pain. Per duplex sonogram, an aneurysm spurium was diagnosed. Compression was held, a compression bandage was placed, and medication was provided with no improvement. On (b)(6) 2018, surgery was performed as treatment. The event required prolonged hospitalization. No additional information was provided regarding this issue.
 
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 that would have contributed to this event. In this case, there was no reported device malfunction associated with the clip delivery system (cds). The reported patient effects of pain, pseudoaneurysm, fistula, thrombosis and surgery are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures. Based on the information reviewed, the reported patient effects of pain, pseudoaneurysm, fistula and thrombosis appear to be related to patient morphology/pathology and/or user technique/procedural conditions. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Subsequent to the previous medwatch report, the additional information was obtained: on (b)(6) 2018, a mitraclip procedure was performed for severe functional mitral regurgitation with minor signs of degeneration. On (b)(6) 2018, the patient had surgery for an av-fistula and aneurysm spurium. The aneurysm spurium was overstitched and a thromboendarterectomy with end to end anastomosis was performed.
 
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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 Key8134249
MDR Text Key129372123
Report Number2024168-2018-09327
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 health professional,study
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/21/2019
Device Catalogue NumberSGC0302
Device Lot Number80621U254
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 Received01/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2018
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: 12/05/2018 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP
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