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

Catalog Number CDS0705-XTW

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)

Event Date 04/15/2023

Event Type  Injury  

Event Description

This is filed to report an air leak during insertion of the xtw clip.It was reported that a patient presented with grade 3+ functional mitral regurgitation (mr) a restricted posterior leaflet, a history of diabetes, coronary artery bypass graft (cabg), and vascular surgery.During a mitraclip procedure, an xt (20928r1013) was positioned lateral on the anterior and posterior (a2p2) leaflets.Leaflet insertion was performed, and the xt was deployed.Transesophageal echocardiogram (tee) was assessed and the clip was stable with an mr reduction to <1.Fifteen minutes had passed, and a single leaflet device attachment (slda) was observed.The posterior mitral leaflet was detached from the clip.It was decided to implant a second mitraclip xtw (20628r196) to stabilize the slda.A new steerable guide catheter (sgc, 20715r159) was prepared, as the previous one was placed on an unsterile surface.As the xtw entered the sgc and reached the tip, the patient¿s pressure dropped and went into asystole.Air bubbles were observed in the left atrium as soon as the xtw exited the sgc tip.It was noted that there was no air in the sgc/system or observed leaks during positioning prior to entering the xtw.Per the physician, air may have been entrapped during insertion of the xtw through the hemostatic valve of the sgc.The patient was managed, but could not hold up pressure and there was a short duration of st elevation.A bypass pump stabilized the patient after two hours, and then was put on iabp.The procedure continued, as the mr was significant at grade 4+.The xtw was implanted, reducing the mr to grade 1.It was noted that there was no issues with sgcs, and during the second attempt to implant the xtw, no air was observed.The patient was hemodynamically stable.There was a clinically significant delay.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 identified no similar incidents reported from this lot.Based on available information and without the device to analyze, the reported arrhythmia associated with the asystole, the reported hypotension associated with the lowered blood pressure, and the reported ekg/ecg changes associated with the st elevation, appear to be due to the air embolism.The cause of the reported air embolism associated with air bubbles in the left atrium could not be determined.The cause of the reported leak / splash associated with the theorized air introduction when the cds was inserted into the sgc could not be determined.The reported patient effects of hypotension, embolism, and arrhythmia/ ekg/ecg change, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical interventions and delay to treatment were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

• 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: 16901782
• MDR Text Key: 314898340
• Report Number: 2135147-2023-02012
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 05/10/2023

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: 07/17/2023
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 20628R196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2023
• Initial Date FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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: 66 YR
• Patient Sex: Female
• Patient Race: Asian