MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0706-XTW

Device Problem Migration (4003)

Patient Problems Angina (1710); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 01/11/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is being filed due to clip slippage, recurrent regurgitation, and worsening heart failure requiring treatment.(b)(6).Patient id: (b)(6).It was reported that on (b)(6) 2024, the patient presented with degenerative mitral regurgitation (mr) with an enlarged left atrium and posterior flail.Two mitraclips ((cds0706-xtw, (b)(6) (medial)) were successfully delivered and deployed, reducing the mr to grade 1+.On (b)(6) 2024, residual, moderate to severe mr was noted.Reportedly, it was thought that one of the two mitraclips (cds0706-xtw, (b)(6)) had slipped off the posterior leaflet.This was observed on a later date.There was no single leaflet device attachment (slda).On (b)(6) 2024, the patient presented to the emergency department with chest pain and atrial fibrillation.On (b)(6) 2024, the patient was seen by the cardiologist for progressive dyspnea on exertion, lower extremity edema, a new cough, orthopnea, paroxysmal nocturnal dyspnea, and severe mr was noted.On (b)(6) 2024, the patient presented with dyspnea, hypotension, mr, and worsening acute heart failure was diagnosed.The patient was admitted to cardiology for treatment.The patient was also covid positive.Medications had been provided.Per imaging, the medial mitraclip (cds0706-xtw, (b)(6)) had slipped off the posterior leaflet.There was no slda noted.On (b)(6) 2024, a deep vein thrombosis (dvt) of the lower extremity was noted.On (b)(6) 2024, per imaging, acute infarcts were observed within the cranium and a cerebrovascular accident (cva-stroke) was diagnosed, likely cardioembolic.There was no acute intracranial hemorrhage.Per physician, the dvt and stroke were unrelated to the mitraclip device.On (b)(6) 2024, moderate to severe mr was noted and a mitral valve replacement was performed.Additional procedures performed included a left atrial maze (for atrial fibrillation) and closure of the left atrial appendage (laa) and atrial septal defect (asd) was performed.Reportedly, once the clips were removed, there was both anterior and posterior leaflet endothelial damage.Per physician, the atrial fibrillation treated with maze was unrelated to the mitraclip device.The asd was deemed related to the steerable guide catheter related and had been closed during the surgery.

Manufacturer Narrative

The additional mitraclip device mentioned in b5 is filed under a separate medwatch report number.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported migration (partial clip movement).The reported tissue injury and recurrent mitral regurgitation (mr) appears to be related to the procedural condition of the partial clip movement.The reported dyspnea, hypotension, heart failure, angina, and swelling/edema appear to be cascading effects of the recurrent mr.Mr, dyspnea, hypotension, heart failure, angina, swelling/edema are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization, medication required, and surgical intervention were results of case-specific circumstances as the patient remained hospitalized, medications were provided, and surgical intervention was performed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the initial report, the additional information was received: on (b)(6) 2024, the patient presented to the emergency room with chest pain.Atrial fibrillation was noted, treated with medications.The event resolved.The physician deemed the atrial fibrillation unrelated to the mitraclip device.The tissue injury noted on (b)(6) 2024 was associated with both implanted mitraclips.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• 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: 18805729
• MDR Text Key: 336506819
• Report Number: 2135147-2024-00925
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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 Expiration Date: 05/23/2024
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30523A1064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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: 1 IMPLANTED MITRACLIP.
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White