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Catalog Number SGC0302
Device Problems Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/05/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number (b)(4). The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional device referenced is being filed under separate medwatch report.
Event Description
This is being filed to report the steerable guide catheter torn tip, difficult to remove, prolonged hospitalization and surgical intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. It was noted poor lv ejection fraction (25%) with massive mitral regurgitation. On (b)(6) 2019, the first xtr clip was successfully deployed in the medial segment of the a2/p2. A second xtr clip delivery system (cds) was advanced to the mitral valve, and the clip was placed lateral to the first xtr clip. The clip grasped the leaflets fine; however, mr increased, and a leaflet tear was suspected. Therefore, the clip was re-opened to be re-positioned. The clip grasped the leaflets and mr was significantly reduced. Then during clip evaluation, it was observed that the clip jumped opened. Since the clip deployment steps were not yet performed, the grippers were raised, and the clip was unlocked to invert the clip and retract from the left ventricle to the leaflet atrium. But it was not possible to close the clip. It was observed that the clip was detached from the dc shaft, but remained on the gripper line. A lasso catheter was introduced to capture the clip and try to close the clip arms. The clip could not be closed, but the clip was able to be fully inverted. The clip was retracted to the steerable guide catheter (sgc), and both the sgc and clip were retracted to over the septum and back to the groin. Surgery was performed to remove the sgc and the cds with the clip attached. The procedure continued with a new cds and sgc. The clip was deployed to further reduce mr and treat the leaflet tear. Treatment of the leaflet tear was suboptimal. Three clips were implanted, reducing mr to 3-4. Extracorporeal membrane oxygenation (ecmo) was needed to stabilize the patient. On (b)(6) 2019, the patient died due to brain edema, acute respiratory failure, cardiogenic shock, congestive heart failure, and mitral valve insufficiency. The three implanted clips were stable on the leaflets at the time of death. The physician stated that the second clip contributed to the patient death due to the clip caused a delay in the procedure that resulted in blood loss and the patient to become unstable. The returned device analysis identified that the steerable guide catheter (sgc) that was used with the reported clip was returned with a deformed and torn soft tip. No material seem to be missing from the soft tip material. It was confirmed by the physician that the sgc tip became torn when the retracted clip was in the inverted position. Retraction of the sgc was difficult due to anatomical challenges. The sgc was ultimately removed through surgery. No additional information was provided.
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Type of DeviceVALVE REPAIR
Manufacturer (Section D)
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
MDR Report Key9197008
MDR Text Key163144322
Report Number2024168-2019-12645
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/11/2020
Device Catalogue NumberSGC0302
Device Lot Number90211U160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2019
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: 10/16/2019 Patient Sequence Number: 1