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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
Catalog Number SGC0302
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Atrial Perforation (2511)
Event Date 04/24/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Based on the information reviewed, the reported atrial perforation likely resulting in hypertension and hemorrhage appears to be related to user technique/procedural circumstances. The reported patient effect of atrial septal defect (atrial perforation), hypertension and hemorrhage 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.
 
Event Description
This is filed to report the steerable guide catheter (sgc) caused an iatrogenic atrial septal defect. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4. The clip delivery system (cds) was advanced to the mitral valve and the clip was implanted, reducing mr to 1-2. The patient had a history of atrial septal defect (asd) and blood flowed from left atrium to right atrium before procedure. Because the asd was present pre-procedure, the steerable guide catheter (sgc) was inserted from another site in the atrial septum. However, when the steerable guide catheter (sgc) was pulled to the right atrium, iatrogenic asd was generated and the amount of blood flowing through the left atrium to right atrium increased. As amounts of bleeding increased from femoral vein during the procedure, blood transfusion was performed. Nevertheless, stable blood pressure could not be obtained without the use of vasopressors. There was confirmation of no pericardial effusion of chordae tendineae, increased mr or mitral stenosis. The pulmonary blood flow ratio increase, so it was decided to insert a percutaneous cardiopulmonary support (pcps) to support the heart function. After inserting the pcps, the patient was transferred without extubating to another hospital to close the asd. However, the asd closure was not performed since hemodynamic stability and the location of the asd was determined to be difficult to place on arrival to the hospital. Th patient is currently undergoing rehabilitation after being extubated and will be discharged from the hospital and is in good condition. 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 Key10038704
MDR Text Key190334432
Report Number2024168-2020-04183
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2020
Device Catalogue NumberSGC0302
Device Lot Number91101U258
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 Received04/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2019
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: 05/08/2020 Patient Sequence Number: 1
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