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

Model Number CDS0706-NTW

Device Problem Entrapment of Device (1212)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Diminished Pulse Pressure (2606); Foreign Body In Patient (2687); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/12/2023

Event Type  Injury  

Event Description

This is filed to report the mitraclip being entangled in the chordae, being deployed in the chordae, causing a clinically significant delay, cardiogenic shock, and unexpected medical intervention.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4+.Imaging was challenging, making the transseptal puncture difficult.A ntw mitraclip was advanced and attempted to grasp the leaflets.Anesthesia had difficulty supporting the patient's blood pressure which made the physician suspect a pericardial effusion.The blood pressure then dropped further and a large pericardial effusion was noted.Chest compressions were performed to regain a pulse.Once a pulse was regained, the ntw clip was attempted to be removed but had now became entangled in the chordae.Troubleshooting was attempted but was unsuccessful.After ten minutes of troubleshooting, the patient blood pressure dropped again and chest compression were performed.The patient recovered briefly, so the physician decide to implant the clip on the anterior leaflet and chordae.Chest compression were completed again and then pericardiocentesis.The patient is currently stable.Mr was reduced to grade 1+ but was noted to have a severely depressed ejection fraction due to global hypoperfusion.It was the physician's opinion that the pericardial effusion was caused by the transseptal puncture and was unrelated to the mitraclip system.No additional information was provided.

Manufacturer Narrative

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

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 this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported entrapment of device (clip entangled with chordae) was due to procedural circumstances (i.E., chest compression being performed while the clip was advanced) as the system could be offset by chest compression.The reported image resolution poor was associated with challenging imaging windows.A cause of the reported hypotension appears to be secondary to the pericardial effusion and diminished pulse.The reported cardiac tamponade (from pericardial effusion) was due to a traumatic transseptal puncture, as per the physician.The reported diminished pulse appears to be due to the cardiac tamponade.The reported heart failure (diminished ejection fraction) was due to the reported shock (hypoperfusion).A cause of the hypoperfusion could not be determined.The reported foreign body in patient was associated with the clip being implanted only on anterior leaflet and chordae.The reported patient effects of hypotension, heart failure, shock, arrhythmias, and cardiac tamponade, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical interventions (cpr/ chest compressions, pericardiocentesis, medical decision to deploy the entrapped clip) and delay to treatment/ therapy were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17237358
• MDR Text Key: 318187198
• Report Number: 2135147-2023-02874
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: 05415067037435
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

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: 11/13/2023
• Device Model Number: CDS0706-NTW
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 21111A1049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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): Required Intervention
• Patient Sex: Female