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

Catalog Number UNK CDS

Device Problem Expulsion (2933)

Patient Problems Dyspnea (1816); Hematoma (1884); Embolism/Embolus (4438); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 04/27/2023

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.B3: date of event is estimated.D4: the udi is unknown due to the part/lot number was not provided.D6: date of implant and explant are estimated.Attachment: article titled ¿transcatheter mitral valve repair clip embolization to the right coronary artery".

Event Description

This is filed to report complete clip detachment, embolism, tissue damage and recurrent mitral regurgitation it was reported a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4.Two clips were implanted, reducing mr to a grade of 1.Roughly one year post procedure, the patient returned to the hospital with progression of disease.It was noted the two clips remained stable on the leaflets.An additional mitraclip procedure was performed.To treat mr, an additional clip was implanted, reducing mr.Roughly six months post second mitraclip procedure, the patient returned to the hospital with a symptom of shortness of breath.Echocardiography showed one of the three implanted clips had expulsed and embolized into the right coronary artery (rca) ostium and an atrial septal defect (asd) was observed, causing mr to return to a grade of 4.The other two clips were noted to be stable on the mitral valve.Several days post returning to the hospital, the patient underwent mitral valve replacement.The completely detached clip was removed from the rca ostium.For asd treatment, a closure device was implanted.It was noted a hematoma in the left ventricle and a small tissue tear near the rca ostium were observed, requiring treatment with a patch and stitches.Additional information can be found in the attached article titled, "transcatheter mitral valve repair clip embolization to the right coronary artery".

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record (lhr) and corrective action tracking system for the web (catsweb) database for the reported lot could not be performed as the lot number and part number are unknown.Based on the information reviewed, and due to limited information available from the article the cause of the reported clip expulsion cannot be determined.The reported clip embolism is a cascading effect of the reported clip expulsion.The reported tissue injury, hematoma, mr and dyspnea appear to be a cascading effect of the reported clip embolism.Additionally, the reported patient effects of tissue injury, dyspnea, mitral regurgitation, embolism, and hematoma are listed in the instructions for use and are known possible complications associated with mitraclip procedures.The reported medical intervention, surgical intervention, removal of foreign body, and hospitalization were the result 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: 17944336
• MDR Text Key: 325795548
• Report Number: 2135147-2023-04543
• 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,Followup
• Report Date: 11/06/2023

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?: 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: Not provided
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 11/06/2023
• 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
• Treatment: IMPLANTED MITRACLIP.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male