MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-NTW

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

Patient Problems Cardiac Arrest (1762); Respiratory Failure (2484); Diminished Pulse Pressure (2606); Pericardial Effusion (3271)

Event Date 04/15/2021

Event Type  Injury  

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 the reported event.Based on the available information, a cause for the reported pericardial effusion and cardiac arrest could not be determined.The reported diminished pulse and respiratory failure appear to have been results of the reported cardiac arrest.The reported patient effects of pericardial effusion, cardiac arrest, and respiratory failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical interventions, required medication, and hospitalization or prolonged hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report pericardial effusion requiring cardiopulmonary resuscitation (cpr).It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4.Two clips were implanted, reducing mr 1-2.The patient was stable.On to the recovery area, patient was noted to be pulseless and not breathing.Cpr was performed.Medication was given and the patient was intubated, and the pulse returned.There was a small pericardial effusion noted prior to the procedure and during the procedure.Transesophageal echocardiography (tee) noted the pericardial effusion to be slightly worse after procedure.A stat echocardiogram at bedside showed the pericardial effusion had not worsened since the post procedure evaluation in cath lab.It was not suspected to be the cause of the patient's cardiopulmonary arrest.The clips were noted to be stable.The patient did not show an acute cause for the patient¿s cardiac arrest.The patient is now undergoing additional diagnostics and medical care post cardia arrest.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11791471
• MDR Text Key: 249518649
• Report Number: 2024168-2021-03895
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2021

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: 08/09/2021
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 00808U169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• 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: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 67