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

Model Number CDS0701-NTW

Device Problem Positioning Failure (1158)

Patient Problem Tissue Damage (2104)

Event Date 01/26/2021

Event Type  Injury  

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 the reported event.A review of lot-specific similar complaints revealed no indication of a lot-specific product quality issue.Based on available information, the reported positioning failure (leaflet grasping and leaflet capture) and poor image resolution appear to be due to challenging patient anatomy.The reported tissue damage appears to be a cascading effect of the reported positioning failure.Additionally, tissue damage is listed in the ifu as a known possible complication associated with mitraclip procedures.There is no indication of product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report tissue damage.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced to the mitral valve and noted thin leaflets and a heavily calcified shelf under the posterior leaflet, causing difficulty to visualize the clip.Several grasping attempts were made but adequate reduction of mr could not be achieved.There was loss of leaflet capture after the grippers had been lowered about 5-10 times.An additional posterior leaflet flail was noted after several attempts.The physician believed this to be due to the repeated grasping attempts.Ultimately, the clip was removed still attached to the delivery system.The procedure took extra time, but the length of time did not change the outcome.The patient is stable and recovering.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: 11325029
• MDR Text Key: 231953860
• Report Number: 2024168-2021-01181
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• 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: 02/12/2021

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: 09/13/2021
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 00914U256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Weight: 52