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

Catalog Number CDS0705-NT

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Bradycardia (1751)

Event Date 07/27/2023

Event Type  Injury  

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 an air leak that resulted in an air embolism, bradycardia, and intervention.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 3.A nt (lot: 21110r1037) was attempted to be inserted into the steerable guide catheter (sgc), but air was noted in the sgc.Air was attempted to be aspirated with a syringe but could not be removed.It was suspected there was an issue with the clip delivery system (cds) clip introducer hemostatic valve.Air entered the patient anatomy.Most of the air was able to be aspirated, but a small amount remained in the patient and caused temporary bradycardia.The nt cds was removed and a replacement device was used to complete the procedure successfully, reducing mr to grade 1.There were no other patient effects.No additional information was provided.

Manufacturer Narrative

Returned device analysis confirmed the reported leak and the reported suspected issue with the clip introducer (product quality problem) as the silicone valve inside the clip introducer (ci) was observed to be torn (material split, cut or torn).A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.All available information was investigated, and the reported leak appears to be related to the issue with the ci (product quality problem) which was identified to be a tear in the silicone valve inside the ci; however, how the silicone valve got torn cannot be determined.Air embolism resulting in bradycardia appears to be due to the leak that was caused from the tear in the silicone valve of the ci.Air embolism and bradycardia are known possible complications associated with mitraclip procedures.Unexpected medical intervention was 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: 17585531
• MDR Text Key: 321556744
• Report Number: 2135147-2023-03634
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/12/2023

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 Expiration Date: 11/09/2023
• Device Catalogue Number: CDS0705-NT
• Device Lot Number: 21110R1037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 08/22/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• 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
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 38 KG