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

Model Number CDS0701-XTW

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2022

Event Type  Injury  

Event Description

The patient presented to the cath lab for a mitraclip repair.The procedure was going according to plan.The mitral clip delivery device was advanced and deployed.According to tee imagery mv regurge was reduced to trivial.The device placement and amount of regurge was checked multiple times, and the clip was released from the retrieval wire.The clip remained closed at the time of release.The clip then spontaneously opened due to an error in manufacture.Attempts were made to introduce a second clip, but they were unsuccessful.The delivery system was withdrawn and the patient went to or for open mitral valve repair and retrieval of mitraclips.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM XTW
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez rd; temecula CA 92591
• MDR Report Key: 15635744
• MDR Text Key: 302057272
• Report Number: 15635744
• 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: 10/14/2022

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 Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 20224R138913038,20511R15391305
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 30295 DA
• Patient Sex: Male