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

Catalog Number UNK CDS

Device Problems Off-Label Use (1494); Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Tricuspid Valve Insufficiency/ Regurgitation (4453); Swelling/ Edema (4577)

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) and complaint history reviews were not performed because this incident was based on an article review and 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 was unable to be determined.The reported off-label use was associated with the use of the mitraclip device on the tricuspid valve.The reported tricuspid regurgitation was a cascading event of the reported slda.The reported dyspnea was a cascading event of the reported tricuspid regurgitation.The cause of the reported edema was unable to be determined.The reported patient effects of dyspnea, edema, and tricuspid regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Attachment: article titled ¿fundamental roles of intracardiac echocardiography and fluoroscopy in redo tricuspid transcatheter edge-to-edge repair procedure¿.

Event Description

It was reported in an article that in early 2023, the patient underwent an off-label mitraclip procedure to treat torrential tricuspid regurgitation (tr).Three clips were implanted (2 xtw on anterior/septal leaflets and 1 xtw on posterior/septal leaflets).Over the past 2 months, the patient required hospitalization due to increased shortness of breath (new york heart association functional class iii) and lower extremity edema that was refractory to medical therapy.Transthoracic echocardiogram (tee) showed torrential tr from a single leaflet device attachment (slda) of a septal-anterior clip.The patient underwent additional off-label mitraclip procedure to stabilize the slda and the recurrent tr.3d ice and fluoroscopy were the primary imaging modalities used during the redo t-teer procedure with supplemental tee from transgastric views.Ice imaging assessed gripper motion, visualized the clip pass through the tricuspid valve without disrupting the prior clips, and confirmed leaflet insertion during grasping and before release.Two additional mitraclip xt clips were placed between the prior clips (septal anterior and septal posterior), reducing tr to mild-moderate, which was maintained at his 30-day follow-up.No additional information was provided.Details are listed in the attached article titled, ¿fundamental roles of intracardiac echocardiography and fluoroscopy in redo tricuspid transcatheter edge-to-edge repair procedure¿.

• 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: 18991899
• MDR Text Key: 338883686
• Report Number: 2135147-2024-01365
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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
• Date Manufacturer Received: 03/06/2024
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male