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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Renal Failure (2041); Cardiac Tamponade (2226); Vascular Dissection (3160); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 09/04/2023

Event Type  Injury  

Event Description

This prospective study aimed to conduct a clinical process cost analysis to evaluate all upcoming costs of mitral valve transcatheter edge-to-edge repair (m-teer).Between 2020 and 2021, 51 patients were treated using the pascal system, and 56 were treated using the mitraclip system.All mitraclip patients had technical success.The following adverse effects that were reported: minor bleeding complication, major vascular complication, pneumonia, acute kidney failure.Major bleeding complications mainly occurred at access sites closed by a z-shaped suture and were successfully managed by manual compression.After the one-year follow-up period, hospitalization for heart failure occurred.A retrospective analysis was conducted on 709 m-teer patients treated between the years 2010 and 2020, and m-teer-related complications were rare but were associated with higher costs, mainly due to prolonged hospitalization.The analysis focused on m-teer-related complications and their associated costs, including pericardial tamponade, stroke, acute kidney injury (aki), bleeding, and vascular complications.Hemodialysis was required in 2 out of 70 patients with aki.In three patients, pericardiocentesis was performed during the procedure and in one patient after the procedure.Minor and major bleeding occurred, requiring transfusion of packed red blood cells.This analysis provides valuable insights into reducing expenses by modifying the process of m-teer.Details are listed in the attached article titled, "comparison of costs associated with transcatheter mitral valve repair: pascal vs mitraclip in a real-world setting, bmc health services.".

Manufacturer Narrative

B3: date of event is estimated.D4: the udi number is not known as the part and lot numbers were not provided.D6: the implant date is estimated.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 mr, hemorrhage, infection, renal failure, cardiac tamponade, heart failure, cerebrovascular accident, and vascular dissection.Mr, hemorrhage, infection, renal failure, cardiac tamponade, heart failure, cerebrovascular accident, and vascular dissection 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.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 17913505
• MDR Text Key: 325406290
• Report Number: 2135147-2023-04454
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 10/11/2023

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: 09/16/2023
• Initial Date FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male