MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP; MITRAL VALVE REPAIR DEVICES

Model Number MBR0203

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2019

Event Type  malfunction  

Event Description

Mitraclip, 81126u295, was inserted, positioned and closed appropriately in the mitral valve with verbal guidance of the abbott rep.Challenging the lock, the clip opened slightly and did not look as if it closed securely and showed a gap in fluoroscopy.The clip was opened and closed per abbott rep.Recommendations.A gap still was visible.Upon discussion with rep, it was decided to remove clip and insert new clip.A new clip, 81126u293, was inserted, positioned and closed appropriately with the verbal guidance of the abbott rep.Prior to deployment, the lock was again challenged.This time the clip remained fully closed on fluoroscopy.The gripper line was assessed for removability.Then, the lock line was fully removed while the clip remained in stable position with the arms fully closed during this process.After lock line removal.Before the lock could be challenged again, the clip "snapped open" suddenly in a fully open position (about 120 degrees).At that point it could no longer be closed or opened at all despite multiple maneuvers suggested by the rep.The clip remained completely "unresponsive".The abbott rep.Made phone calls to other reps and the education person for abbott for further instruction.The clip was carefully pulled back into the left atrium and then pulled through the septum without too much of a damage to the septum itself.Contralateral venous access was obtained and one of the clip arms was snared with a goose neck snare.The clip was deployed.The cds was removed while the gripper lines were kept in place.A seconds en snare was advanced through the guide and used to pull the clip partially into the guide.Both were removed together while the per-closure sutures successfully closed the venous access sites.

• Brand Name: MITRACLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 8955753
• MDR Text Key: 156299828
• Report Number: 8955753
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2019,06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MBR0203
• Device Lot Number: 81126U295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA