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

Model Number SGC0301

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 04/22/2020

Event Type  Death  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional mitraclip device referenced is filed under a separate medwatch report number.

Event Description

This is being filed to report the steerable guide catheter (sgc) leak requiring aspiration and air embolism resulting in death.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The first ntr mitraclip was deployed at a2p2 without issue.The second clip delivery system (cds) was advanced, a and m knob were applied to gain height to advance to the mitral valve.Once the cds crossed the valve, the device needed to be rotated in order to be parallel to the first clip when it was noted the clip was stuck on the deployed clip and was pulling on it.The cds was pushed out in an attempt to gain distance from the deployed clip however the clip was stuck and unable to be moved at all.Troubleshooting was performed per the instructions for use (ifu) however the clip would not move.M knob was taken off to release tension in the cds and it appeared the clip changed orientation and was rotating towards the deployed clip.The clip then seemed to jump free from the deployed clip.An attempt was made to invert the clip however was unsuccessful and the clip remained stuck under the posterior mitral leaflet (pml).All m was removed and an attempt was made to invert the clip again however there was a lot of tension on the arm positioner knob and the clip arms would not respond.It was thought the chordae was wrapped around the clip arms or grippers, not allowing it to move.An attempt was made to rotate the arm positioner again and it was noted the clip had detached from the cds as the mandrel had broken.An attempt was made to deploy the clip; the lock line and gripper lines were removed.A snare device was advanced and the clip was able to be brought closer to the valve however became stuck under the anterior mitral leaflet (aml).The clip then became disconnected from the mandrel and the snare device lost the clip.The clip was lodged under the aml and not able to be moved.The cds was removed and a 11fr sheath was inserted into the sgc when it was noted column was lost.Aspiration was performed however the patient's blood pressure dropped and the patient crashed.Chest compressions were started.While doing compressions, the physician was able to insert a second snare device and grab the lodged clip and bring it back to the ivc.Chest compressions were performed for 40 minutes however the patient was never resuscitated and died.Per the physician, the cause of death is unknown however it is possible an air embolism entered the patient when column was lost the second time.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported steerable guide catheter (sgc) leak was not confirmed during returned device analysis.A review of the lot history record revealed no manufacturing nonconformities reported to this lot.Additionally, a review of the complaint history identified no other complaints reported from this lot.All available information was investigated and a definitive cause for the reported leak could not be determined in this complaint.The reported air embolism and hypotension were likely an outcome of loss of fluid column and are due to procedural circumstances/operational context.A definitive cause for the reported cardiac arrest and death could not be determined in this complaint.The patient effects of emboli (air), hypotension, cardiac arrest and death are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product quality 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: 10021101
• MDR Text Key: 189739817
• Report Number: 2024168-2020-04064
• 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: 06/10/2020

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: 11/14/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 91114U358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/04/2020
• Supplement Dates Manufacturer Received: 06/08/2020
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM; 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 44