MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Perforation (2001); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/04/2022

Event Type  Injury  

Manufacturer Narrative

The clip was explanted.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Patient id: (b)(6).This is filed for mitral regurgitation, requiring additional intervention.It was reported that this was a mitraclip procedure, performed on (b)(6) 2021, treating degenerative mitral regurgitation (mr) of grade 3+.One clip was implanted and the mr was reduced to grade 2+.On 03/04/2022, the patient was re-hospitalized for optimization of pulmonary hypertension prior to cardiovascular surgery.Recurrent mr of severe grade was noted.Surgery was performed, with repair of an atrial septal defect (asd), repair of the mitral valve, repair of the tricuspid valve and left atrial appendage ligation.The mitral valve repair procedure was performed using the patient's mitral valve tissue: the anterior leaflet and chordal attachments were detached from the annulus, and sewn to the posterior annulus.The implanted mitraclip was explanted.Transfusions were performed on 03/05/2022 and on 03/06/2022.On 05/02/2022, the patient died of causes related to complications from the cardiovascular surgery.Per study physician, the patient's death is unrelated to the implanted mitraclip.No additional information was provided.

Manufacturer Narrative

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.The reported patient effects of perforation, hypertension, mitral regurgitation (mr), death, and hemorrhage are listed in the instructions for use (ifu) and are known possible complications associated with mitraclip procedure.Based on the available information the cause of the reported perforation, hypertension and hemorrhage cannot be determined.The cause of the reported death is worsening patient condition.The cause of the reported mr and anemia are due to the surgical intervention.The reported hospitalization, surgical intervention, and medical intervention are the results of case-specific circumstances.There is no indication of product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14661530
• MDR Text Key: 293850432
• Report Number: 2024168-2022-06281
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

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 Expiration Date: 06/24/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10624R171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 59 KG