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

Model Number CDS0701-NTW

Device Problems Positioning Failure (1158); Unintended Movement (3026)

Patient Problem Mitral Regurgitation (1964)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

This is filed to report the clip failed establish final arm angle (efaa).It was reported this was a mitraclip procedure performed to treat grade 4 functional mitral regurgitation (mr).The first clip was implanted, without issue.To further reduce mr, a second clip was placed and mr was reduced.However, after unraveling the lock line, mr increased; clip deployment was stopped.It was observed the clip was only on one leaflet.The lock line was re-wrapped, and the o-ring and the cap were put back on the device.The leaflets were re-grasped and clip deployment was started a second time; however, when testing the lock, the clip opened.Establishing final arm angle (efaa) was tested again, and it failed.Troubleshooting was unsuccessful, the lock failed.The clip was not implanted and was removed.Another clip was advanced and the leaflets were grasped without issue, with good leaflet insertion.However, when performing efaa the clip, although the clip remained closed; it was noted that the clip was only on one leaflet.The clip was not implanted and was replaced with an xtw clip.A total of two clips were implanted, mr was reduced to 2.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The results of the return device analysis could not confirm the reported unintended movement as no issues were noted during returned device analysis and the device functioned as intended.The discrepancy between what was reported vs what was noted during the return device analysis is likely due to user technique/procedural circumstances possibly resulting from the curves/tension on the device.The reported positioning failure could not be replicated during the return device analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have resulted in this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.All available information was investigated and a conclusive cause for the reported unintended movement could not be determined in this incident.The reported positioning failure appears to be due to user technique while grasping the leaflets that resulted in one of the leaflets slipping off the clip arms.

• 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
• MDR Report Key: 11369099
• MDR Text Key: 234746435
• Report Number: 2024168-2021-01396
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2021
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 00723U121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP(X1); STEERABLE GUIDE CATHETER
• Patient Age: 74 YR
• Patient Weight: 72