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 Endocarditis (1834); Failure of Implant (1924); Mitral Valve Stenosis (1965); Renal Failure (2041); Respiratory Failure (2484); Pericardial Effusion (3271); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 04/16/2022

Event Type  Death  

Event Description

This is filed to report the patient deaths.This article discusses clinical outcomes after mitral valve surgery in failed mitraclip procedures.The article concluded that failure of mitraclip represents a challenging situation limited by high-risk profiles of patients and limits the possibility of surgical valve repair, shown by a high rate of mitral valve replacement.Secondary surgery was associated with moderate 30 day and post discharge outcomes.Therefore, a careful evaluation of patients undergoing mitraclip is of paramount importance.Complications noted after the mitraclip procedures specifically for the mitraclip device included single leaflet device attachment (slda), rehospitalization, mitral regurgitation, mitral stenosis, tissue damage, pericardial effusion, endocarditis, edema, respiratory failure, renal failure, re-clipping, surgical intervention, surgical repair and patient deaths.Specific patient information is documented as unknown.Details are listed in the article, titled ¿mitral valve surgery after failed mitraclip-operation for the inoperable?¿.

Manufacturer Narrative

The clips remain in patients.The devices will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The reported serious injuries and malfunction referenced are filed under a separate medwatch report number.Date of death: estimated (b)(6) 2022.Date of event: estimated (b)(6) 2022.The unique device identifier (udi) is unknown because the parts and lot numbers were not provided.Implant date: estimated (b)(6) 2022.Literature: "mitral valve surgery after failed mitraclip-operation for the inoperable?".

Manufacturer Narrative

The device was not returned for analysis.A lot history record review and complaint history review could not be performed as this complaint is based on an article, and no device/lot information was provided.Causes for the reported death could not be determined.Death is listed in the instructions for use as a known possible complication associated with mitraclip procedures.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: 15212205
• MDR Text Key: 297743568
• Report Number: 2135147-2022-00724
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

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: 07/28/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 10/11/2022
• 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): Death
• Patient Age: 76 YR
• Patient Sex: Male