MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number UNK SGC03

Device Problems Difficult or Delayed Positioning (1157); Unintended Movement (3026)

Patient Problems Air Embolism (1697); Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Perforation (2001); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Date of event is estimated.The udi number is not known as the part and lot number were not provided.Literature attachment: article title: "acute right ventricular failure and right-to-left shunt due to massive coronary air embolism following mitraclip.

Event Description

This is filed to report leak, atrial perforation, medical intervention, air embolism, and prolonged hospitalization.It was reported in a literature review that this was mitraclip procedure to treat mitral regurgitation.A steerable guide catheter (sgc) was advanced to the mitral valve, and the clip was successfully deployed.However, after the clip delivery system was removed, the patient developed hypotension, complete atrioventricular block [arrhythmia], and oxygen saturation decreased from 96% to 48%.The patient's hemodynamic were stabilized by oxygen and medication.Imaging showed a left to right shunt.The physician stated that the cause of the shunt was possibly due to the sgc insertion was complicated by severe tricuspid regurgitation and an enlarged right atrium/ventricle.Coronary angiography was performed from the left femoral access due to an inferior st-elevation and showed a coronary flow at the mid right coronary artery that indicated a possible air embolism and heart failure.Several aspirations attempts were made to remove the air.The coronary flow was restored, and the patient was stable.However, post-procedural computed tomography revealed a small amount of air in the right atrium without any signs of systemic embolism.The physician stated the cause of air was possibly due to position of the distal end of the sgc against the left atrial wall when the clip delivery system was removed may have resulted in suction of air in the left atrium indication the sgc may moved in an intended direction.The patient was discharged at 36 days indicating prolonged hospitalization.It is unknown at this time if the left to right shunt was treated.One clip was implanted, reducing, mr.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The lot history record and similar complaint review was not performed because this incident was based on an article review and no device/lot information was provided.Based on this information, the reported sleeve steering issue resulting in air embolism appears to be due to procedural circumstances.The reported difficult positioning appears to be due to challenging patient anatomy.The reported perforation was due to challenging patient anatomy.The reported patient effects of hypotension, hypoxia, arrhythmia and heart failure are possibly resulted from perforation and air embolism.The reported patient effects of perforation, air embolism, hypotension, hypoxia, arrhythmia and heart failure are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported unexpected medical intervention, test result and required medication were results of case specific circumstances there is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13834326
• MDR Text Key: 287802965
• Report Number: 2024168-2022-02920
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• 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
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female