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); Unspecified Infection (1930); Pain (1994); Paresis (1998); Renal Failure (2041); Multiple Organ Failure (3261); Syncope/Fainting (4411); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 06/21/2023

Event Type  Death  

Event Description

This article presents a case of an 85-year-old male who underwent tr transcatheter edge-to-edge repair (teer) for treatment of symptomatic moderate-to-severe functional mitral regurgitation (mr).The patient has a history of chronic kidney disease, cerebral hemorrhage, and endovascular treatment for an iliac aneurysm was hospitalized for hf five times.Two nt mitraclip second generation were implanted with no reported issue, reducing mr to trivial.Three months after the procedure, the patient returned with lumbar pain lasting for approximately one week.The patient's laboratory tests showed worsening of his renal function and a high inflammatory reaction of unknown origin.The patient was started on antibiotic therapy, which included vancomycin and ceftriaxone.On day 3, the patient experienced fever (maximum of 37.8°c) and his blood culture was positive for methicillin-resistant staphylococcus aureus.On day 4, the patient suddenly complained of left-side dominant hemiparesis, resulting in multiple strokes evaluated by magnetic resonance imaging.On day 10, a repeated blood culture was positive again for the same agent; therefore, we evaluated the mitral valve by transesophageal echocardiography with a suspicion of invective endocarditis (ie).Imaging results showed a 16 × 14mm unstable vegetation attached to the medial clip.On day 10, the patient was scheduled to undergo surgical mitral valve replacement; however, he presented with melena and a serious disturbance of consciousness.Surgical intervention was discontinued, and the patient succumbed to multiorgan failure.No additional information was provided.Details are listed in the attached article titled, ¿infective endocarditis after transcatheter edge-to-edge repair for severe mitral regurgitation; a case report and a systematic review¿.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Based on available information, the cause of the reported pain associated with lumbar pain, the reported renal failure (treatment with medication(s)) associated with worse renal function, the reported infection, the reported mitral valve insufficiency/ regurgitation (recurrent mr), the reported paresis associated with hemiparesis, the reported cerebrovascular accident associated with stroke, the reported endocarditis, the reported syncope/fainting associated with disturbance of consciousness, the reported multiple organ dysfunction syndrome (dysfunction) associated with multiorgan failure, and the reported death / expired, could not be determined.The reported patient effects of death, endocarditis, cerebrovascular accident, renal failure, multiorgan failure, pain, infection, and mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization 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.B2, b3, d6: dates estimated.D4: the udi number is not known as the part and lot number were not provided.Attachment: article titled, "infective endocarditis after transcatheter edge-to-edge repair for severe mitral regurgitation; a case report and a systematic review"na.

• 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: 17379039
• MDR Text Key: 319586339
• Report Number: 2135147-2023-03148
• 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: 07/24/2023

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: 06/30/2023
• Initial Date FDA Received: 07/24/2023
• 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: 85 YR
• Patient Sex: Male