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

Catalog Number CDS0502

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

Patient Problems Hemolysis (1886); Hemorrhage/Bleeding (1888)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

The clip remains implanted.Investigation not yet completed.A follow-up report will be submitted with all additional relevant information.

Event Description

This will be filed to report during the procedure it was suspected hemolysis occurred.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 3+.One clip was implanted, reducing mr to 1-2.After the procedure, the anesthesiologist reported that hematuria occurred right after grasping.The procedure continued because it was determined the clip did not affect the hematuria.There was no treatment for the hematuria.The physician suspects hemolysis occurred but not sure of the relevance to the procedure.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.The investigation determined the reported hematuria (hemorrhage) appears to be related to the hemolysis.However, a cause for the hemolysis cannot be determined.Hemorrhage and hemolysis are listed in the mitraclip instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10593809
• MDR Text Key: 208787767
• Report Number: 2024168-2020-08055
• 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: 11/11/2020

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 Expiration Date: 04/06/2021
• Device Catalogue Number: CDS0502
• Device Lot Number: 00403U138
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Weight: 70