MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

Device Problem Difficult to Remove (1528)

Patient Problems Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Pericardial Effusion (3271)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.A review of lot-specific similar complaints revealed no similar incidents reported to the lot.Based on available information, the reported difficult to remove (anatomy) appears to be due to a combination of challenging patient anatomy and procedural conditions.It should be noted that the reported patient effects of pericardial effusion, hypotension, and thrombosis as listed in the ifu, mitraclip g4 system, are known possible complications associated with mitraclip procedures.The cause for the reported poor image resolution appears to be challenging patient anatomy.A cause for the reported patient effects of pericardial effusion and hypotension could not be determined.The reported thrombosis appears to be a cascading effect of the treatment with medication.Based on the information reviewed, there is no indication of product issue with respect to manufacture, design or labeling.

Event Description

This report is being filed as the clip was difficult to remove and a worsening pericardial effusion was observed following along with a blood clot.It was reported that the patient presented with degenerative mitral regurgitation (mr) grade 4++, bi-mitral leaflet prolapse and flail, torn chordae, heavily calcified chordae, leaflets and mitral annulus.The patient also presented in severe heart failure with pre-existing pleural effusions and small pericardial effusion.Despite the pre-existing conditions, a mitraclip procedure was performed in hopes for mr relief.An arterial line, along with a central line, were placed with difficulty.The transseptal access into the left atrium was performed without issue.Reportedly, imaging was difficult due to patient anatomy, particularly the calcification.The steerable guide catheter was placed without issue.Following, the clip delivery system (cds0701-xtw, 00923u168) advanced.When in the ventricle and looking at a 3d image, the operator rotated and counter clocked slightly with the clip delivery system.A few grasps were performed without great grasps/reduction.A few spots were tried and then they decided to get back in the atrium and re-set.Reportedly, there was no issue with grasping but rather they were attempted for the best grasp.During grasping attempts, the xtw clip became stuck on the chordae.The clip was inverted when the pre-existing torn chordae was stuck behind one gripper.The patients blood pressure started dropping and the pericardial effusion had increased in size.The procedure was paused.A pericardiocentesis was performed and medications were provided.The hypotension improved and the mitraclip procedure continued.The xtw clip was removed from the chordae without tissue injury noted, a good grasp was obtained, and the clip was implanted without further issues.Per physician, it is unknown if the xtw mitraclip contributed to the growing pericardial effusion with subsequent hypotension, and treatments of.Following, an nt mitraclip was successfully implanted next to the xtw mitraclip.The mr had been reduced to moderate.Throughout the procedure, the pericardium was drained.Post-procedure, a heparin protagonist, protamine, was provided to help reduce the pericardium effusion.Following, due to the protamine effects, a blood clot was observed in the pericardium.A surgical pericardial window was created, removing the clot.The pericardial effusion had resolved and the patient was in stable condition.The event did not require prolonged hospitalization.There was no additional adverse patient sequela reported.There was no clinically significant delay.No additional information was provided regarding this issue.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• 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 Key: 11293818
• MDR Text Key: 230744777
• Report Number: 2024168-2021-00943
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2021

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: 09/22/2021
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 00923U168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; XTW MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR