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

Catalog Number CDS0702-XTW

Device Problem Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 08/23/2023

Event Type  Death  

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 death.It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 3-4.Transesophageal echocardiogram (tee) imaging was of poor quality.Heparin was administered immediately after the transseptal puncture, maintaining an activated clotting time (act) level 250 sec.A xtw clip was inserted, but when in the left atrium it appeared to be moving in opposite directions than the applied knob on fluoroscopy.It was thought the clip may have been misaligned in the steerable guide catheter.When inserting the cds into the sgc, the physician reported that the longitudinal marker on the steerable sleeve shaft shaft aligned with the alignment marker on the guide hemostasis valve.The clip was pulled back to the sgc to re-align, but the patient suffered hemodynamic collapse - direct blood pressure drop to systolic 40mmhg, and a massive pericardial effusion was immediately noted.Due to the poor imaging, it was unknown if the clip contacted anatomy and it was unknown where the exact location of the effusion was.The clip was removed and the sgc was moved to the right atrium.Pericardiocentesis was performed along with administering of protamin 7.500ie, and blood transfusions.The pericardial effusion developed into cardiac tamponade.Patient received medical resuscitation with all emergency medications - suprarenin 1:10 ml at the beginning to suprarenin perfusor pure.Despite the efforts, the patient eventually died under resuscitative measures 35 minutes after the onset of the pericardial effusion.It cant be ruled out that the mitraclip system may have caused tissue damage or contributed to the pericardial effusion due to poor imaging.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 complaints reported from this lot.Based on available information, the reported hypotension (therapy/non-surgical treatment, additional) appears to be due to the cardiac tamponade.The reported cardiac tamponade (treatment with medication(s)), and the reported hemorrhage/blood loss/bleeding (blood transfusion) associated with the blood loss, were due to the pericardial effusion.The cause of the pericardial effusion (therapy/non-surgical treatment, additional) could not be determined.The cause of the reported unintended movement (sleeve steering issues) associated with the dc moving in the opposite direction than expected could not be determined.The cause of the reported death / expired (cardiac death) could not be determined.The reported image resolution poor was associated with visualization difficulty.The reported patient effects of death, cardiac tamponade, hypotension, hemorrhage, and pericardial effusion, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and medication required were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 3-4.Transesophageal echocardiogram (tee) imaging was of poor quality.Heparin was administered immediately after the transseptal puncture, maintaining an activated clotting time (act) level 250 sec.A xtw clip was inserted, but when in the left atrium it appeared to be moving in opposite directions than the applied knob on fluoroscopy.When the m-knob was applied the clip delivery system (cds) moved towards the atrial roof.It was unknown if the cds was misaligned in the steerable guide catheter (sgc).When inserting the cds into the sgc, the physician reported that the longitudinal marker on the steerable sleeve shaft aligned with the alignment marker on the guide hemostasis valve.The clip was pulled back to the sgc to re-align, but the patient suffered hemodynamic collapse - direct blood pressure drop to systolic 40mmhg, and a massive pericardial effusion was immediately noted.Due to the poor imaging, it was unknown if the clip contacted anatomy and it was unknown where the exact location of the effusion was.The clip was removed and the sgc was moved to the right atrium.Pericardiocentesis was performed along with administering of protamin 7.500ie, and blood transfusions.The pericardial effusion developed into cardiac tamponade.Patient received medical resuscitation with all emergency medications - suprarenin 1:10 ml at the beginning to suprarenin perfusor pure.Despite the efforts, the patient eventually died under resuscitative measures 35 minutes after the onset of the pericardial effusion.It cant be ruled out that the mitraclip system may have caused tissue damage or contributed to the pericardial effusion due to poor imaging.No additional information was provided.

• 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: 17760848
• MDR Text Key: 323575686
• Report Number: 2135147-2023-04012
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/03/2023

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 Catalogue Number: CDS0702-XTW
• Device Lot Number: 30606R3054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• 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): Death