MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0702-XTW

Device Problems Entrapment of Device (1212); Difficult to Open or Close (2921)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/28/2023

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, a patient presented emergently with cardiac decompensation due to grade 3-4 mixed mitral regurgitation (mr).The plan was to assess the patient¿s condition post-bypass operation, with respect to pre-operative risk (euroscore i 26.7%), recompensation, and interdisciplinary discussion.It was decided to attempt a mitraclip intervention on (b)(6) 2023.During the procedure while testing the grippers, one was not able to raise or lower.During troubleshooting attempts to simultaneously actuate the grippers, the clip became caught in the chordae.The clip was unable to be removed from the chordae and remained attached to the clip delivery system (cds) (sheath).The cds could not be safely removed without damaging the valve due to the entanglement.The valve remained open with the leaflets push down from the entanglement, and worsened grade 4 mr.The patient remained intubated, ventilated, hemodynamically stable, and clip in situ while transferred to cardiac surgery to remove the clip from the chordae and eventually remove the system.There was no tissue damage observed or pericardial effusion.An emergent mitral valve replacement was performed with a 33mm epic valve, a tricuspid valve replacement with a 36mm non-abbott device, and left ventricular reconstruction with a non-abbott cardiac patch.The patient was transferred to the cardiosurgical intensive care unit for recovery, with high dose catecholamine therapy and invasive ventilation.The patient¿s cardiorespiratory system continued to decompensate, requiring cardiopulmonary reanimation (cpr).Implantation of an arteriovenous ecmo (extracorporeal membrane oxygenation) via inguinal vessel was not performed due to malign pulmonary edema and from stents within the arteriae iliacae on both sides.Patient died on (b)(6) 2023, at 00:37.The cause of death was multi-organ failure.Per the physician, the death was caused by the patient¿s comorbidities and preexisting condition, as well as the mitraclip entanglement that required an emergent surgical intervention.The patient was not suited for surgery.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All information was investigated and based on information reviewed and without the device to analyze, a cause for the reported single gripper actuation issue resulting in entrapment of device (clip becoming caught in anatomy) during troubleshooting cannot be determined.Worsening mitral valve insufficiency / regurgitation was due to the procedural circumstances associated with the valve remaining open with the leaflets pushing down from the entanglement.Pulmonary edema, cardiac arrest, multiple organ dysfunction syndrome (multi-organ failure) and subsequent death appear to be cascading effects related to patient and procedural conditions associated with the need to perform emergent surgery due to clip entanglement on a patient with comorbidities and not suitable for surgery.Mitral regurgitation, edema, cardiac arrest, system (multiple) organ failure and death are listed in the mitraclip g4 system instructions for use as known possible complications associated with mitraclip procedures.Surgical intervention, hospitalization, unexpected medical interventions and medication required were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18562984
• MDR Text Key: 333465259
• Report Number: 2135147-2024-00320
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 30920R2009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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
• Patient Outcome(s): Death