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

Catalog Number CDS0705-NTW

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

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Ventricular Fibrillation (2130)

Event Date 06/09/2023

Event Type  Injury  

Event Description

This is filed to report ventricular fibrillation, cardiac arrest, myocardial infarction, and air embolism.It was reported that on (b)(6) 2023 a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4.After advancing the clip delivery system (cds) into the patient, the patients blood pressure (bp) dropped and the patient went into ventricular fibrillation.A shock was administered with no response.After several more shocks the patient went into cardiac arrest.Cardiopulmonary resuscitation was performed, additional shocks were administered, and the patients heart rate returned.However, the bp was still low and there was st elevation.Subsequently, all mitraclip devices were removed and a percutaneous cardiopulmonary support (pcps) device.At this time air was suspected and the coronary artery was completely occluded due to the drop in bp resulting in right ventricular infarction.The procedure was then concluded with no change in mr and no clips implanted.Two days later the pcps device was removed and the patient remained stable.No additional information was provided.

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.Based on available information, the reported ventricular fibrillation (defibrillation), and the reported cardiac arrest (cpr), appear to be due to the myocardial infarction.The reported myocardial infarction (mi) (pti), and the reported non specific ekg/ecg changes associated with the st elevation, appear to be due coronary artery occlusion that occurred due to hypotension.The cause of the reported hypotension (therapy/non-surgical treatment, additional) could not be determined.The cause of the reported air embolism (therapy/non-surgical treatment, additional) could not be determined.The reported patient effects of embolism, hypotension, myocardial infarction, cardiac arrest, ventricular fibrillation, and ekg/ecg changes (cardiac arrhythmias), as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.The reported unexpected medical interventions 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 (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: 17211458
• MDR Text Key: 317989152
• Report Number: 2135147-2023-02809
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2023
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 20810R2058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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 Age: 83 YR
• Patient Sex: Male
• Patient Weight: 71 KG