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); Renal Failure (2041); Foreign Body In Patient (2687); Pericardial Effusion (3271); Embolism/Embolus (4438); Unspecified Tissue Injury (4559)

Event Date 04/01/2018

Event Type  Injury  

Event Description

This research article was a prospective study designed to evaluate aims to investigate the initial experience of the transcatheter edge-to-edge repair (teer) system, including the g4 system, particularly in terms of short-term outcomes in patients with mitral regurgitation (mr).Complications identified in the study included: hospitalization, in-hospital death, mortality at 30 days, single leaflet device attachment (slda), device embolization, leaflet tear, mitral valve surgery, all stroke, pericardial effusion, major bleeding, acute kidney injury, iatrogenic atrial septal defect closure.In conclusion, the ocean-mitral registry has demonstrated the short-term outcomes of teer systems, including the g4 system, in symptomatic patients with primary and secondary mr.The acute procedural success rate in the g2 system was excellent, and that in the g4 system was expected to improve with the multidisciplinary heart valve team approach.Details are listed in the article titled, "short-term outcomes following transcatheter edge-to-edge repair | insights from the ocean-mitral registry".

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 additional patient effects of death and malfunctions reported in the article are captured under separate medwatch reports.The device was not returned for analysis.The lot history record (lhr) and similar incident reviews were not performed because no lot information was provided.Based on available information and due to the limited information available from the article, the cause of the reported slda, expulsion, death, renal failure, embolism, foreign body in patient, cerebrovascular accident, hemorrhage, pericardial effusion, and tissue injury were unable to be determined.The reported patient effects of death, embolism, tissue injury, cerebrovascular accident, pericardial effusion, hemorrhage, and renal failure, the reported hospitalization, unexpected medical intervention, and surgical intervention were results of case-specific circumstances.There is no indication of a product quality 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: 17805106
• MDR Text Key: 324112872
• Report Number: 2135147-2023-04149
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/24/2023

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: 09/06/2023
• Initial Date FDA Received: 09/24/2023
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male