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 Stroke/CVA (1770); Endocarditis (1834); Fever (1858); Low Blood Pressure/ Hypotension (1914); Shock (2072); Nervous System Injury (2689); Embolism/Embolus (4438); Unspecified Tissue Injury (4559)

Event Date 03/24/2023

Event Type  Death  

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 determined the reported tissue injury and endocarditis appear to be related to patient conditions as no issue was noted during the procedure and the patient had a long list of medical history issues.The reported fever, hypotension, cerebrovascular accident, nervous system injury, embolism and shock appear to be cascading effects of the endocarditis and death was due to the septic shock.The reported hospitalization, medication required, and unexpected medical intervention were results of case-specific circumstances.Shock, fever, hypotension, death, endocarditis, cerebrovascular accident, nervous system injury, embolism, and tissue injury are listed in the instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.A4: as this event is from a literature review, the specific patient weight was not provided.B3: the event date is estimated as the date of publication.B2: the death date is estimated as the date of publication.D4: the udi is unknown as the part and lot numbers were not provided d6a: the implant date was estimated as 8 month prior to the publication date.D6b: the explant date was estimated as the publication date.Article titled "mitral valve infective endocarditis in a dialysis patient with a tunneled dialysis catheter and prior mitraclip implantation: an autopsy case.".

Event Description

This is filed to report endocarditis and subsequent death.It was reported that a patient presented with severe functional mitral regurgitation (mr), mild tricuspid regurgitation (tr), left ventricular dilation, end-stage renal failure with autosomal dominant polycystic kidney disease, and currently in treatment for hemodialysis.Mr was between the middle scallop of the anterior leaflet (a2) and the posterior leaflet (p2), due to valve ring enlargement and tethering.A mitraclip procedure was performed.One mitraclip nt device was implanted between a2 and p2.There were no intraoperative complications or adverse patient effects.Mr improved from severe to mild.Eight months post-operative, the patient developed a fever, hypotension, and dialysis could not be performed.The patient was hospitalized.Echo revealed a large vegetation at the site of the mitraclip implantation.A diagnosis of cardiac device-related infective endocarditis (cdrie) was made.An mri revealed multiple cerebral infarctions.Blood culture revealed methicillin-resistant staphylococcus aureus (mrsa).The patient developed disturbances of consciousness, which was suspected to be another cerebral infarction which was caused by embolization from the vegetation.Antibiotic therapy was administered, however; the patient did not respond to the medication and died of peripheral circulatory failure, or septic shock.An autopsy was performed and hematoxylin-eosin (h-e) staining and elastica-masson staining were performed.This confirmed there was significant valve tissue destruction.Details are listed in the attached article titled, "mitral valve infective endocarditis in a dialysis patient with a tunneled dialysis catheter and prior mitraclip implantation: an autopsy case.".

• 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: 16843047
• MDR Text Key: 314266593
• Report Number: 2135147-2023-01882
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2023

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: 04/06/2023
• Initial Date FDA Received: 05/01/2023
• 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: 66 YR
• Patient Sex: Male