MAUDE Adverse Event Report: ABBOTT VASCULAR 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 Hemolysis (1886)

Event Date 10/07/2021

Event Type  Injury  

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 the information reviewed, the reported hemolysis appears to be related to patient conditions.The reported patient effect of hemolysis is listed in the instructions for use as a known possible complication associated with mitraclip procedures.Additionally, the reported test results and hospitalization were a result of case-specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

This is filed to report hemolysis and prolonged hospitalization it was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted that an intra-aortic balloon pump (iabp) was placed prior to the mitraclip procedure.On (b)(6) 2021, two clips (01022u191, 01022u186) were successfully implanted, reducing mr to1.On (b)(6) 2021, after a blood test was performed, the physician stated that the patient possibly developed hemolysis due to elevated lactate dehydrogenase (ldh).It is unknown at this time if the hemolysis is related to the implanted clips or due to an auxiliary circulation by iabp that was previously implanted.The clips remain stable on both leaflets, and mr is 1.Additional treatment was not performed and the patient will remain hospitalized.Additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12729672
• MDR Text Key: 279832647
• Report Number: 2024168-2021-09789
• 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
• Report Date: 11/01/2021

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: 10/22/2021
• Device Catalogue Number: CDS0705-NT
• Device Lot Number: 01022U191
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 45