MAUDE Adverse Event Report: ABBOTT VASCULAR UNKNOWN MITRACLIP; VALVE REPAIR

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

Patient Problems Death (1802); Dyspnea (1816); Edema (1820); Endocarditis (1834); Pulmonary Edema (2020)

Event Date 02/16/2020

Event Type  Death  

Manufacturer Narrative

Date of event estimated as(b)(6) 2020.Date of death estimated as (b)(6) 2020.(udi#): in the absence of a reported part number, the udi cannot be calculated.Date of implant estimated as (b)(6) 2020.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Literature attachment: mitraclip-associated endocarditis: emergency department diagnosis with point of care ultrasound.(b)(4).

Event Description

This is filed to report post mitraclip procedure the patient presented with pulmonary edema, infective endocarditis and death it was reported that a mitraclip procedure was performed on unknown date to treat mitral regurgitation (mr).Four years later, the (b)(6) year old man presented to the emergency department with shortness of breath.Further history revealed that he had experienced decreased oral intake because of dental pain and had experienced a 29-lb weight loss in the previous 9 months without night sweats.He was afebrile, with a blood pressure of 108/62 mm hg and a heart rate of 70 beats/min, but was tachypneic, with a respiratory rate of 22 breaths/min and oxygen saturation of 94%.He appeared chronically ill with increased respiratory effort, diminished left-sided breath sounds, and pitting edema of the lower extremities.The remainder of his examination was unremarkable.Because of his dyspnea, point of care ultrasound (pocus) of the heart and lungs was performed, revealing a left pleural effusion, pleural abnormalities consistent with pneumonia, and mitral valve hardware associated with a highly mobile vegetation.A diagnosis of infective endocarditis was made, broad-spectrum antimicrobials were initiated, and the patient was admitted where subsequent consultations with cardiology, infectious disease, and cardiac surgery were sought.Follow-up comprehensive transthoracic echocardiogram (tte) confirmed the findings.Blood cultures later grew corynebacterium gram-positive rods.The patient did not desire invasive therapies or procedures and was treated with palliative measures.His condition declined and he died on hospital day 18.No additional information was provided.

Manufacturer Narrative

D4 (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for analysis.A review of the lot history record could not be performed due to unknown lot information.Based on the information reviewed, a conclusive cause for the reported patient effects cannot be determined.The patient effects of dyspnea, edema, endocarditis, death, and pulmonary edema as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: UNKNOWN MITRACLIP
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10011533
• MDR Text Key: 189434292
• Report Number: 2024168-2020-03997
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 04/29/2020
• Supplement Dates Manufacturer Received: 04/30/2020; 07/20/2020
• Supplement Dates FDA Received: 05/15/2020; 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR