MAUDE Adverse Event Report: MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0705-NT

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 07/05/2021

Event Type  Injury  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional clip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is filed to report hypersensitivity it was reported that the mitraclip procedure performed on (b)(6) 2021 was to treat functional mitral regurgitation (mr) with a grade of 3.Two clips (01031u152, 01028u184) were successfully implanted reducing mr to 1.On (b)(6) 2021, the patient was transferred to another hospital.A blood test was performed with no issues.On (b)(6) 2021, the patient was discharged.On (b)(6) 2021, the patient returned for a follow-up.An issue was detected with the blood test.Amiodarone (anti-arrhythmic drug) was stopped.0n (b)(6) 2021, echocardiography and re-examination was performed.The result became worse.The patient was re-admitted to the hospital.Then on (b)(6) 2021, a liver biopsy was performed and it was discovered that the patient had autoimmune hepatitis.The physician stated it is unknown if the clips caused or contributed to the hypersensitivity.Additional treatment was not performed.Both clips remain stable on the leaflets and mr is 1.On (b)(6) 2021, the patient was discharged.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, a cause of the reported hypersensitivity could not be determined.The reported patient effect of hypersensitivity as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.The reported required medication and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed report, the following information was received: additional medication was administered for treatment.After (b)(6) 2021, the patient improved and hepatitis was resolved.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• MDR Report Key: 12507361
• MDR Text Key: 272505581
• Report Number: 2024168-2021-08365
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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 Expiration Date: 10/30/2021
• Device Catalogue Number: CDS0705-NT
• Device Lot Number: 01031U152
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2020
• 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; 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 42