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

Catalog Number CDS0702-NTW

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 02/15/2023

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device is filed under separate medwatch report number.

Event Description

This is filed to report a death.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 3-4.The steerable guide catheter (sgc) was advanced to the left atrium with no reported issue.The ntw clip was advanced slowly in the direction of the left upper pulmonary vein.While advancing the clip, imaging was difficult as echo-view was only at the tip of the clip.The guide was pulled back to the septum and m-knob was used.A structure was observed on the tip of the clip.The m-knob was released, and the clip was retracted further.At this point, the patient was hemodynamically unstable.Evidence of pericardial effusion (pe) was observed in imaging.The physician attempted to stabilize the patient; however, it was not possible and it resulted in a cardiac arrest.Resuscitation and subxiphoid puncture were started.A pleural catheter was inserted, removing approximately 300 ml of blood, including short-term recovery of the circulatory situation.After an obvious tear in the area of the entrance to the pulmonary vein was noted, immediate antagonism of the anticoagulation was implementation.A 9 f sheath was placed in the pericardia without improvement.Cardiac arrest persisted and no further options for intervention were possible.Resuscitation was stopped, and the patient died.After the clip was removed, few shreds of mucous membrane were observed at the tip of the clip, the device is intact and functional.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported adverse event without identified device or use problem during procedure could not be replicated in a testing environment as it was related to patient/procedural conditions.However, the clip functionality was tested and the clip and knobs function as intended.There was no damage observed to the clip or gripper arms and frictional elements.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, a cause for the reported tissue injury could not be determined.The reported pericardial effusion, hypotension, bradycardia, cardiac arrest, and death appear to be cascading events of the tissue injury.Furthermore, the reported patient effects of tissue injury, hypotension, bradycardia, cardiac arrest, and death are listed in the ifu as known possible complications associated with mitraclip procedures.The reported unexpected medical intervention is the result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.4440 removed.

Event Description

N/a.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 16522333
• MDR Text Key: 311066017
• Report Number: 2135147-2023-01120
• 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: 05/08/2023

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: 04/04/2023
• Device Catalogue Number: CDS0702-NTW
• Device Lot Number: 20404R206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2022
• 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): Other; Required Intervention; Death