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

Catalog Number UNK CDS

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

Patient Problems Bradycardia (1751); Hypoxia (1918); Mitral Valve Stenosis (1965); Myocardial Infarction (1969); Pain (1994)

Event Date 07/23/2022

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report number.Attachment: article titled ¿paradoxical left-to-right device embolization complicating transcatheter mitral valve edge-to-edge repair.¿.

Event Description

This is filed to report death.It was reported through a research article that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4, posterior prolapse, flail, and dilated left atrium (la).It was noted the patient had a history record that included stage three chronic kidney disease, chronic pleural effusions, hypertension, mild coronary atheroma, hypothyroidism, pleural plaques with a restrictive pattern on spirometry three xtr clips were implanted, reducing mr to a grade of 2.It was noted that after the procedure, a small left to right shunt was observed.At the time, no additional treatment was performed.Six months later, the patient was admitted to the hospital due to heart failure.Transthoracic echocardiogram (tte) was performed and showed mr had increased to a grade of 4.Radiography then observed that one of the implanted clips had completely detached and embolized in the left groin.Tissue damage was also observed on the mitral valve and the atrial septal defect (asd) from the first procedure was still present.One month later, a second mitraclip procedure was performed.One clip was successfully implanted, reducing mr to a grade of 2.However, the mean pressure gradient increased to 6.5mmhg.It was noted no treatment was performed to remove the embolized clip as no clinical symptoms were being caused by the clip.To treat the asd from the initial procedure, an asd closure device was implanted.Three days later, the patient developed hypoxia and left shoulder discomfort.Electrocardiogram (ecg) was performed and showed bradycardia.Therefore, the patient was intubated and ventilated, and a pacemaker was implanted.Nineteen days later, the patient passed away.Additional information can be found in the attached article, titled ¿paradoxical left-to-right device embolization complicating transcatheter mitral valve edge-to-edge repair.¿.

Manufacturer Narrative

The device was not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot number regarding the complaint device was not provided.The investigation was unable to determine a cause for the reported mitral stenosis, hypoxia, pain, myocardial infarction, bradycardia, and death.Mitral stenosis, hypoxia, pain, myocardial infarction, bradycardia, and death are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported unexpected medical intervention was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 16233578
• MDR Text Key: 308007210
• Report Number: 2135147-2023-00270
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 01/31/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 01/31/2023
• 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): Death
• Patient Age: 86 YR
• Patient Sex: Male