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

Model Number CDS0701-XTW

Device Problem Expulsion (2933)

Patient Problems Embolism (1829); Foreign Body In Patient (2687)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

The additional devices referenced are filed under separate medwatch report numbers.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 incidents reported from this lot.Based on the available information, the reported expulsion (complete clip detachment) appears to have been a result of challenging patient anatomy.The reported patient effects of foreign body in patient and embolism appear to have been cascading events of the reported expulsion (complete clip detachment).Additionally, the reported patient effects of foreign body in patient and embolism as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional information is captured under a different report and filed under emdr-(b)(4).

Event Description

This is being filed to report the clip completely detaching from the leaflets and migrating.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Although imaging was difficult, one clip was successfully placed at a2p2.A second clip delivery system (cds) was advanced medial to the first clip.During grasping, it was noted the first clip had detached from the anterior leaflet (single leaflet device attachment (slda)).The second clip was deployed to stabilize the slda clip, reducing mr to 2.Per the physician, the slda was due to friable leaflets and difficult imaging.Approximately two weeks after the procedure was performed on (b)(6) 2020, the patient was readmitted for worsening heart failure and was experiencing dyspnea.X-ray was performed where it was noted the slda clip was no longer on the valve.The clip had completely detached and was in the hepatic vein.Additionally, the second clip implanted on (b)(6) 2020, could not be seen on the valve either.The mr had increased to 4.No additional information was provided.

• 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: 11287777
• MDR Text Key: 230553430
• Report Number: 2024168-2021-00914
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2021

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: 06/01/2021
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 00601U146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2020
• 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): Other