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

Catalog Number CDS0702-XT

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Cardiogenic Shock (2262); Pericardial Effusion (3271)

Event Date 11/15/2023

Event Type  Injury  

Event Description

It was reported that a mitraclip procedure was performed on (b)(6) 2023 to treat functional mitral regurgitation (mr) grade 4.A mitraclip xtw was advanced to the valve and was deployed successfully.On 16 september 2023, the was noted to be detached from the posterior leaflet (single leaflet device attachment (slda)) on postoperative transesophageal echocardiogram (tee).Mr was recurrent grade 4.On (b)(6) 2023, a mitraclip xt was then attempted to be implanted to stabilize the slda.The patient presented with a pre-existing pericardial effusion of 200-300 milliliters (ml).During placement the patient became increasingly unstable.The patient became more hypotensive and developed tachyarrhythmia absolute with 150 beats per minute (bpm).The patient was given 150 mg amiodarone administered after valve passage.The blood pressure continued to fall and the patient was in cardiogenic shock.Grasping was completed with the mitraclip, and the patient developed asystole.Cardiopulmonary reanimation is started.After three minuets of cardiopulmonary resuscitation (cpr) and 3 mg of suprarening, rosc (return of spontaneous circulation) occured.Leaflet insertion was then completed and the clip was deployed.After deployment the patient developed asystole again.Cpr was performed for five minutes, with return to rosc.After reanimation, the ejection fraction (ef) was limited to approximately 45%.Since there was still a tachyarrhythmia absolute with 160/min, and the blood pressure was 78/48 mmhg, cardioversion was performed.Mr was reduced was to trace.The pericardial effusion has increased and the patient remained hemodynamically unstable, so pericardiocentesis was performed where 700ml of blood was drained.The patient was intubated and ventilated and transferred to the intensive care unit (icu) under catecholamine medication.The patient was reported to be hemodynamically stable with the pericardial drainage in place.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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, the reported pericardial effusion resulting in tachycardia, hypotension, cardiogenic shock and cardiac arrest (asystole) appear to be related to patient and procedural conditions associated with a pre-existing pericardial effusion which may have worsened by the cds during the procedure.Pericardial effusion, tachycardia, cardiogenic shock, cardiac arrest and hypotension are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical interventions, medication required and hospitalization 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: 18290793
• MDR Text Key: 330043500
• Report Number: 2135147-2023-05390
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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 Expiration Date: 12/14/2023
• Device Catalogue Number: CDS0702-XT
• Device Lot Number: 21215R1053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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; Hospitalization
• Patient Weight: 53 KG