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

Model Number SGC0301

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The clip delivery system is filed under a separate medwatch report number.

Event Description

This is filed for leak requiring intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.The transseptal puncture was performed; however, it was noted that the puncture was very superior.The steerable guide catheter (sgc) was prepared without issue.The sgc was advanced and it was noted that when the left atrial pressure monitoring was connected, air bubbles were in the line.Aspiration was performed, and this seemed to cause more air bubbles.The air was able to be aspirated and no air entered the patient anatomy.The device was used without additional issue.The clip delivery system (cds) was then prepared for use.During device preparation, the device was flushed and the clip seemed to open and close without issue.However, it was noted that the delivery catheter (dc) handle would not move.It was noted that the flush line was clamped at the back end.The line was unclamped and flushed appropriately.The dc handle was then able to move without issue.The device was advanced into the patient anatomy.Due to the transseptal puncture location, additional "+" knob was used, which brought the device lower.Additional "a" knob was used to gain more height.When the clip was in the left atrium, during straddling, a gap was noted by the sleeve.The dc handle could not be pulled back any more to close the gap.It was noted that the anterior leaflet caught on the gripper.The grippers were cycled (raising / lowering) in an attempt to free the leaflet.It was then noted that the grippers could not be raised or lowered.The physician tried to individually raise/lower the grippers; however, that did not work.It appeared that the grippers were affixed to the shaft.The clip was then pulled flush to the sgc, and the leaflet was freed.There was no tissue damage.The physician was unable to fully pull the clip into the sgc and pulled hard.The clip popped off the clip delivery system and remained attached to the lock line.A cut-down procedure was performed at the groin in order to remove all devices.The procedure ended with no clips implanted.There was no adverse patient effect or a clinically significant delay in procedure.The patient remained in stable condition post procedure.A second mitraclip procedure will be scheduled for a future date.No additional information was provided.

Manufacturer Narrative

The returned device analysis confirmed the reported leak, and also torn silicone valve was observed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated.The reported leak appears to be a cascading event of observed torn silicon valve.A cause for the observed torn silicone valve can not be determined.The reported additional therapy/non-surgical treatment was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10485362
• MDR Text Key: 205460214
• Report Number: 2024168-2020-07319
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00131U140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 55