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

Catalog Number CDS0702-XTW

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This is filed to report a leak and break.It was reported that a mitraclip procedure was performed to treat a mixed mitral regurgitation (mr) grade 3 with an enlarged atrium.After first establishing final arm angle (efaa) was performed, a leak was noted at the red cap at the luer lock.When the physician attempted to fasten it, the luer lock broke, increasing flow.The leak was sealed by hand and the second efaa was performed and the clip was deployed without any issues.Mr was reduced to grade 1.After the procedure, the guide was removed and the physician realized there was a kink at the tip of the guide.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Event Description

N/a.

Manufacturer Narrative

All available information was investigated, and the reported leak / splash was not confirmed via device analysis.The reported break was confirmed via device 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.The investigation determined the reported break appears to be related to a potential product quality issue.The exception investigation evaluated the reported issue, and the engineering group determined the root cause to be missed steps during manufacturing as cured fillets that are supposed to be present on the inside of the dc handle were missing.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 16064453
• MDR Text Key: 308470902
• Report Number: 2135147-2022-02744
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 20609R180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• 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: STEERABLE GUIDE CATHETER