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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR

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ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Model Number SGC0301
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 02/03/2021
Event Type  Injury  
Manufacturer Narrative
The device will not be returned for evaluation; the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional mitraclip devices referenced in b5 are filed under separate medwatch report numbers.
 
Event Description
This is filed to report atrial perforation it was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+. It was noted that the patient had a severely rotated heart causing imaging to be very challenging. An ntr clip was inserted and the leaflets were successfully grasped. The clip passed the final arm angle test and both the gripper line and lock line were flossed without issues. The lock line was successfully removed, but the physician removed the gripper line prior to removing the release pin. After the release pin was removed, the actuator knob was turned eight times without issues. However, the actuator knob was unable to retract. The actuator knob was then rotated a few more times in the counterclockwise direction and was able to be retracted. However, while pulling on the actuator knob, the physician removed the actuator assembly from the device. The clip was still not deployed and troubleshooting was attempted, but ultimately unsuccessful. Therefore, the patient was transferred to surgery. While in surgery, the clip delivery system (cds) had to be cut down in order to detach the clip. After the clip was cut down, mitral valve replacement was performed. A few hours after mitral valve replacement, the patient was brought back to surgery due to bleeding. It was then observed that a shunt had occurred in the atrial septum. It was noted that no treatment was performed to treat the shunt. The following day, the patient coded; therefore, the chest was opened, and the heart was massaged. Unfortunately, the patient was unable to recover and passed away. The physician stated the patient passed away due to an aortic bleed at the sight of cannulation (ascending aorta). No additional information was provided.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key11373077
MDR Text Key233311364
Report Number2024168-2021-01420
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
Type of Report Initial,Followup
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/22/2021
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number00621U158
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 Received06/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2020
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: 02/24/2021 Patient Sequence Number: 1
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