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

Catalog Number UNK CDS

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

Patient Problem Hemolysis (1886)

Event Date 08/30/2018

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Literature titled: a hybrid technique for treatment of commissural primary mitral regurgitation.

Event Description

This is filed to report post procedure, the patient had hemolysis requiring blood transfusion.It was reported through a research article identifying a patient with a mitraclip which developed hemolysis at 1-day post procedure which required two-unit blood transfusion.Improved with transfusion and medical management.Details are listed in the attached article, "a hybrid technique for treatment of commissural primary mitral regurgitation".No additional information was provided.

Manufacturer Narrative

B3, d6: dates estimated.The device was not returned for analysis and a review of the lot history record could not be performed as the part and lot information regarding the complaint devices were not provided.Based on the information reviewed, and due to the limited information available (no specific information regarding the individual patient), a cause for the hemolysis cannot be determined.The reported patient effect of hemolysis as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Although a conclusive cause for the reported patient effect, and the relationship to the device, if any, cannot be determined, there is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

Additional review of the article, it was noted that when the clip was implanted an occluder was implanted as well during the procedure.No additional information was provided.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Na - attachment: [article cn 033339.Pdf].

• Brand Name: MITRACLIP CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10134943
• MDR Text Key: 194554111
• Report Number: 2024168-2020-04836
• 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
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 06/15/2020; 07/20/2020
• Supplement Dates FDA Received: 07/08/2020; 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention