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

Catalog Number CDS0702-XTW

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

Patient Problems Hematoma (1884); Pericardial Effusion (3271)

Event Date 05/28/2023

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report death.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade of 4.The first clip was implanted with no reported issue.It was decided to implant a second clip.After grasping the leaflets with the second clip, the anesthesiologist observed a change in blood pressure and heart rate.Echo images showed pericardial effusion.The clip was opened and pericardiocentesis was performed.After patient stabilization, the clip was implanted, reducing mr to grade 1.Due to continuous pericardial effusion, the physician decided of additional intervention to resolve the effusion.The patient referred for sternotomy where hematoma was found.The physician used glue to stop the bleeding.Subsequently, the patient expired.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 pericardial effusion (medical treatment) appears to be due to pressure from hematoma in the posterior wall.The cause of the reported hematoma (therapy/non-surgical treatment, additional) could not be determined.The cause of the reported death / expired could not be determined.The reported patient effects of pericardial effusion, hematoma, and death, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

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: 17153004
• MDR Text Key: 317439908
• Report Number: 2135147-2023-02653
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CY
• 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: 07/18/2023

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: 10/30/2023
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 21031R1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• 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: 1 MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death; Required Intervention