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

Catalog Number UNK CDS

Device Problems Positioning Failure (1158); Incomplete Coaptation (2507); Expulsion (2933)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Mitral Valve Stenosis (1965); Myocardial Infarction (1969); Renal Failure (2041); Shock (2072); Pericardial Effusion (3271)

Event Date 10/01/2014

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional patient effects reported in the article are captured under separate medwatch reports.

Event Description

This is reported for several complications related to a study.This research article was a prospective study designed to determine the safety, efficacy, and costs of percutaneous mitral valve leaflet repair (pmvr), using the mitraclip device in a uk setting.Complications identified in the study included: hospitalization, neurological event, additional surgery, myocardial infarction, major bleed, acute kidney injury, cardiogenic shock, pericardial effusion, mitral stenosis, minor bleed, death, device embolism with percutaneous retrieval, single leaflet device attachment (slda), and positioning failure.In conclusion this study shows that percutaneous mitral valve leaflet repair using mitraclip is a relatively safe and effective treatment in patients unable to tolerate surgery and has the potential to reduce ongoing healthcare costs in the uk.Details are listed in the attached article titled, safety, effectiveness and costs of percutaneous mitral valve repair: a real-world prospective study.

Manufacturer Narrative

The devices were not returned for analysis and a review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.Based on the information reviewed, and due to limited information available from the article (no individual information available), a cause for the reported positioning failure, single leaflet device attachment (slda) and expulsion could not be determined.Additionally, due to the limited information available, a cause for the patient effects of pericardial effusion, cerebrovascular accident, myocardial infarction (mi), hemorrhage, renal failure, shock, mitral stenosis and death could not be determined.However, pericardial effusion, cerebrovascular accident/stroke, myocardial infarction (mi), hemorrhage, renal failure, shock, mitral stenosis and death are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported surgical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional death and malfunctions reported in the article are captured under separate medwatch report(s) b3, d6: dates estimated.D4: the udi number is not known as the part and lot number were not provided attachment: article titled, "safety, effectiveness and costs of percutaneous mitral valve repair: a real-world prospective study".

Event Description

N/a.

• 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: 15428195
• MDR Text Key: 300321810
• Report Number: 2135147-2022-01212
• 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: Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

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?: Yes
• 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: 08/23/2022
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 10/21/2022
• Supplement Dates FDA Received: 11/14/2022
• 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): Other; Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male