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

Catalog Number UNK CDS

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

Patient Problems Hemorrhage/Bleeding (1888); Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment: article titled "same-day discharge following elective transcatheter edge-to-edge repair.".

Event Description

This research article was a retrospective study designed to evaluate the outcomes after same-day discharge (sdd) in patients who underwent transcatheter edge-to-edge repair (teer).Complications identified in the study included: single leaflet device attachment (slda), life-threatening bleeding, vascular complication, acute kidney injury, mitral or tricuspid reintervention, readmission due to heart failure, and all-cause mortality.In conclusion, in this single-center retrospective analysis, sdd after teer was feasible with comparable safety outcomes with non-sdd.Patients undergoing isolated tteer, combined mitral and tricuspid teer, or afternoon procedures were more likely to have a delayed discharge (>1 day).As teer continues to become widely adopted, the sdd pathway is likely to be more commonly implemented.A larger prospective study is ongoing to further evaluate the safety and efficacy of the sdd approach.Details are listed in the attached article titled, "same-day discharge following elective transcatheter edge-to-edge repair".

Manufacturer Narrative

The device was not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot number regarding the complaint device was not provided.The investigation was unable to determine a cause for the reported hemorrhage, renal failure, heart failure, and death.Hemorrhage, renal failure, heart failure, and death are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization and unexpected medical interventions were results of case specific circumstances.The reported off-label use was due to the device being used on a tricuspid valve.There is no indication of a product issue with respect to manufacture, design, or labeling.The additional patient effects and malfunctions reported in the article are captured under separate medwatch reports.Literature attachment: article titled, "same-day discharge following elective transcatheter edge-to-edge repair".

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18950815
• MDR Text Key: 338303834
• Report Number: 2135147-2024-01282
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other; Required Intervention; Death; Hospitalization; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Male