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

Catalog Number CDS0704-XTW

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problems Air Embolism (1697); Arrhythmia (1721); Stroke/CVA (1770); Fatigue (1849); Myocardial Infarction (1969)

Event Date 04/13/2023

Event Type  Injury  

Event Description

This report is being filed due to a leak with air embolism, requiring intervention.Crd_947 - repair mr ide study.Patient id: (b)(6).It was reported that on (b)(6) 2023, the patient presented with degenerative mitral regurgitation (mr) grade 4+ with posterior leaflet flail.One mitraclip was successfully implanted.A second mitraclip (cds0704-xtw, 21205r1101) advanced.During use, air was observed in the clip delivery system handle.It was then noted that a faulty three way stop-cock had become loose, allowing air into the delivery system.As treatment, the flushing fluids were increased, the red and lock lever caps were removed to purge the system of air.Some air had embolized into the patient and medication was provided attempting to force air out of the heart apex.The patient went into av block, st-segment elevation was noted, and a myocardial infarction was diagnosed, treated with medication (nitroglycerine).The same mitraclip was implanted without further issues reported, reducing the mr to trace.Following the procedure, the patient was sent to a hyperbaric chamber.The patient has weakness.The events required additional hospitalization.The myocardial infarction resolved.No additional information was provided regarding this issue.

Manufacturer Narrative

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

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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation determined the reported loose stopcock appears to be related to procedural condition due to the faulty stopcock.The reported air embolism appears to be related to the loose stopcock.The reported arrhythmia, myocardial infraction, fatigue, and cerebrovascular accident appear to be cascading effects of the air embolism.Air embolism, arrhythmia, myocardial infraction, fatigue, and cerebrovascular accident are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported unexpected medical intervention, medication required, and hospitalization were results of case specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.H6: medical device problem code 1354 removed.

Event Description

Subsequent to the initial report, the additional information was received: the patient had a non-disabling stroke during the index procedure.

• 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: 16872816
• MDR Text Key: 314718751
• Report Number: 2135147-2023-01960
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2023
• Device Catalogue Number: CDS0704-XTW
• Device Lot Number: 21205R1101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention; Hospitalization; Disability
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White