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

Catalog Number CDS0705-XTW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 08/17/2023

Event Type  Injury  

Event Description

This is filed to report a pericardial effusion and perforation it was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 and a posterior prolapse.An xtw clip was inserted and after grasping, the patient¿s blood pressure decreased to 50mmhg.A pericardial effusion was observed on the echocardiography under the posterior leaflet.Therefore, the clip was removed and the procedure was discontinued.Mr remained at a grade of 4.It was observed the left ventricle ruptured, therefore, open heart surgery with mitral valve replacement was performed.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, a cause for the cardiac perforation and pericardial effusion resulting in hypotension cannot be determined.Pericardial effusion, cardiac perforation and hypotension are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Surgical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, a cause for the cardiac perforation resulting in hematoma and pericardial effusion resulting in hypotension cannot be determined.Pericardial effusion, hematoma, cardiac perforation and hypotension are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Medication required, unexpected medical intervention, surgical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Attachment: article titled ¿left ventricular rupture after leaflet-grasping in transcatheter edge-to-edge mitral valve repair".

Event Description

Subsequent to the initially filed report, additional information was received stating: it was reported a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 and a prolapse of a2, a3, and p3.The patient was presented with worsening shortness of breath, new york heart association iii (nyha iii), and ejection fraction of 55%.The length of the posterior mitral leaflet (pml) was 12.3mm, the anterior mitral leaflet (aml) was 32.2mm, and the prolapse gap was 7.2mm.Xtw clip was advanced to the mitral valve.Independent grasping was performed with p3 grasped first and a3 after, gaining sufficient grasping of both leaflets.Immediately thereafter, the systolic blood pressure dropped to 50mmhg, and circumferential pericardial effusion appeared.Although it is an after-the-fact verification, the clip was sinking into the myocardium as the clip closed.Shunt flow was observed just below the mitral valve annulus on the left ventricular (lv) posterior wall, which formed a hematoma around it.Although immediate drainage was performed, it was decided to convert to surgical repair due to persistent active bleeding.It was determined that retrieval of the clip would risk exacerbation of the bleeding, and a surgical procedure was performed with the clip detached and in place.An approximately 2cm myocardial fissure was observed from the mitral annulus of the p3 to the left ventricular apex.Blood pressure remained around 50 mmhg under catecholamine administration until he was placed on extracorporeal circulation.The myocardial fissure was sutured and covered with a pericardium patch, and mitral valve replacement was performed, implanting 29mm epic mitral valve.No additional information was provided.Details are listed in the attached article titled, ¿left ventricular rupture after leaflet-grasping in transcatheter edge-to-edge mitral valve repair¿.

• 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: 17695683
• MDR Text Key: 322798256
• Report Number: 2135147-2023-03883
• 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,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2024
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 30405R1028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 92 YR
• Patient Sex: Male
• Patient Weight: 50 KG