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

Catalog Number CDS0706-XTW

Device Problem Leak/Splash (1354)

Patient Problem Air Embolism (1697)

Event Date 10/16/2023

Event Type  Injury  

Event Description

It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.A steerable guide catheter (sgc) (30622r1061) was inserted and placed in the left atrium.However, when inserting an xtw clip (30710a1089) into the sgc, air in the fluid column was observed.The clip was removed and re-inserted, but the air remained.Therefore, the clip was removed and the sgc was replaced.The same clip was re-inserted into a new sgc, however, air remained.Therefore, the clip was removed and replaced.The procedure was continued with the new sgc and a new clip.The new clip was successfully implanted, reducing mr to a grade of 1.It was noted air entered the anatomy and was removed naturally from the anatomy.A sign of st-elevation of an electrocardiogram (ekg) was observed, which returned to normal.For treatment, oxygen was administered to the patient.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

Manufacturer Narrative

All available information was investigated, and the reported leak/splash was confirmed via returned device analysis.Additionally, a torn clip introducer valve was observed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and the returned device analysis, the reported leak/splash was a cascading event of the observed torn clip introducer valve.The cause of the observed torn clip introducer valve was unable to be determined.The reported air embolism and ekg/ecg changes are cascading events of the reported leak/splash.The reported patient effects of ekg/ecg changes (cardiac arrhythmias) and embolism, 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.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18107778
• MDR Text Key: 327882106
• Report Number: 2135147-2023-04952
• Device Sequence Number: 1
• Product Code: NKM
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30710A1089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 77 KG