MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number N/A

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

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Perforation of Vessels (2135); Thrombosis/Thrombus (4440)

Event Date 08/17/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.The lot history record review was not performed because this complaint is based on an article review, and no part or lot information was provided.Based on available information, the reported perforation of vessels appears to be due to procedural conditions.The reported hemorrhage, thrombus, and hypotension appear to be cascading effects of the perforation of vessels.Causes for the reported hypoxia, ekg changes, and air embolism could not be determined.The reported patient effects of vessel perforation, hemorrhage, thrombosis, hypotension, ekg changes, and air embolism are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported unexpected medical intervention was the result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.Dates estimated.The udi number is not known as the part and lot number were not provided.

Event Description

This is filed to report the serious injuries requiring intervention.It was reported in an article that the patient underwent a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.There was bleeding in the endotracheal tube after transseptal puncture and heparinization.However, the patient remained hemodynamically stable without pericardial effusion noted and the procedure continued.After the procedure, once the femoral sheath was removed, the patient became unstable with oxygen saturations as low as 60%.The ventilation was compromised by clotted blood obstructing the anesthesia circuit.The endotracheal tube was suctioned, however manual ventilation was needed.The patient developed st-segment elevations and became hypotensive.There was air in the right coronary artery and the mediastinum.There was acute right ventricular failure.The proximal right coronary artery was occluded.This was resolved with wiring.There was thrombus in the left upper lobe bronchi that was thought to be caused by a left upper pulmonary vein perforation.The perforation was thought to have been caused by the tip of the wire during the transseptal puncture.Clotted blood caused the airway obstruction and hypoxia.The thrombus was removed, and there was no active bleeding.The pneumomediastinum improved and the patient fully recovered and was discharged.No additional information was provided.Details are listed in the attached article titled, coronary air embolism and pneumomediastinum after a mitraclip procedure.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• 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: 15422827
• MDR Text Key: 299929464
• Report Number: 2135147-2022-01209
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2022

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 Model Number: N/A
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female