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

Catalog Number CDS0706-XTW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a patient presented with grade 4+ mixed mitral regurgitation (mr), dilated atrium, anterior mitral leaflet flail, flail gap, right heart failure, a restricted posterior leaflet, and an ejection fraction of 10% for a mitraclip procedure.It was noted that the patient was very sick, and considered for a left ventricular assist device (lvad), but it was decided to attempt to treat him with a less invasive procedure.There was nothing wrong with the device, and the clip grasped the leaflets with out incident.Left ventricle (lv) and right ventricle (rv) function dropped when the clip was closed on the leaflet.Ef dropped to 5% and the patient went into peri-arrest with systolic pressure dropping to 60mmhg, and bradycardia.The clip was subsequently removed, and medication was administered by anesthesiology.Extracorporeal membrane oxygenation (ecmo) and a small non-abbott heart pump were placed to stabilize patient.The patient systemically couldn't handle the mitraclip intervention.Per the physician, the adverse event was not caused by the mitraclip devices, but the patient's comorbidities and not being able to handle the procedure.The patient was stable.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, a cause for the reported bradycardia, test results (ejection fraction dropping to 5%) and hypotension cannot be determined.Hypotension and bradycardia are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.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 (MDR)
• 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: 19155478
• MDR Text Key: 340746367
• Report Number: 2135147-2024-01798
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)241021(10)31019R1042
• 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: 05/08/2024

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: CDS0706-XTW
• Device Lot Number: 31019R1042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2023
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 79 KG