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

Catalog Number CDS0705-XTW

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problems Air Embolism (1697); Stroke/CVA (1770); Paresis (1998)

Event Date 03/15/2023

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 a leak, air entering the patient, cerebral infarction and paralysis requiring intervention.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4.The steerable guide catheter (sgc) was prepped without issues.The sgc was inserted in the patient and then the xtw clip delivery system (cds) was inserted into the sgc.Echo images confirmed air in the left atrium.The cds was immediately removed and the air was aspirated.The same cds was inserted again, but air was noted to be pushed into the sgc.Both the cds and the sgc were removed from the patient and replaced.The procedure was completed successfully with the replacement devices, reducing the mr to a grade of 1.A day after the procedure, on (b)(6) 2023, paralysis of the left upper extremity was confirmed, and the patient was diagnosed with cerebral infarction.It was thought the cerebral infarction and associated paralysis was due to the air entering the patient during the mitraclip procedure.In addition, while recovering the patient developed an infection from an unrelated dialysis catheter insertion site, and developed sepsis.The patient died on (b)(6) 2023 in the physician's opinion, the death was entirely due to the septic infection and unrelated to the mitraclip procedure.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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on available information and without the device to analyze, the cause of the reported leak/splash was unable to be determined.It should be noted that the mitraclip instructions for use states under the delivery catheter preparation section that ¿loosen the lock lever cap to de-air.Do not turn lock lever cap more than ½ turn in the ¿open¿ direction.After de-airing, tighten the lock lever cap.¿ the reported improper or incorrect procedure (failure to follow steps / instructions) is associated with turning the lock lever cap past the instructed amount.The reported air embolism was a cascading event of the reported leak/splash.The cause of the reported stroke was unable to be determined.The reported paresis was a cascading event of the reported stroke.The reported patient effect of stroke and embolism as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Additionally, this event and the imaging provided by the account were further reviewed by the clinical r&d (research and development) engineer, and the reviewer stated that ¿one (1) echocardiographic still image was provided.The image is a bicaval view in which the sgc has been advanced across the septum with the cds fully inserted and extending into the left atrium.There are notable orb-shaped artifacts located in the left atrium, creating a refraction like effect in the image that are not consistent with typical anatomy.These artifacts are presumably the air bubbles observed in the left atrium during cds insertion and aligns with the reported incident details.".The event was also further reviewed by an abbott medical affairs team.The reviewer stated that ¿the mitraclip procedure did not cause the patient¿s death.During the procedure, it was noted that an air embolism was identified in the left atrium.The air was removed from the left atrium and a new device was used to complete the procedure.As stated by the site, the patient woke up from the general anesthesia with no issues or paralysis at 1500 hours on (b)(6) 2023.On (b)(6) 2023 1200 hours the patient had paralysis of the left upper extremity and cerebral infarction as identified by ct.It is in my opinion that this cerebral infarction was not related to the identified air embolism during the procedure.Had the stroke been from an air embolism, clinical signs of a stroke should¿ve have been present when the patient awoke from general anesthesia.It is unknown what had caused the cerebral infarction but the patient progressed medically with an infection and ultimately sepsis from a dialysis catheter which then led to the patient expiring on (b)(6) 2023.¿.

Event Description

Subsequent to the previously implanted report, additional information was received: it was reported that while de-airing/flushing the cds during prep, the lock lever cap was unscrewed by more than a half of a turn.No additional information was provided.

• 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: 16710200
• MDR Text Key: 313007062
• Report Number: 2135147-2023-01564
• 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: 05/23/2023

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: 12/19/2023
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 21219R1004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• 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; Life Threatening; Hospitalization; Disability
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 49 KG
• Patient Race: Asian