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

Catalog Number CDS0706-NT

Device Problems Break (1069); Difficult to Remove (1528); Device Damaged by Another Device (2915)

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

This is filed to report a gripper line break and tissue damage.It was reported that a patient presented with grade 4+ functional mitral regurgitation (mr), dilated left ventricle (lv), shallow chordae with visible tension, distorted papillary muscles, and subvalvular structures for a mitraclip procedure.It was noted that imaging was challenging due to acoustic shadowing.It was difficult to simultaneously see both leaflets and clip arms.The nt was the second clip attempted, but got stuck on first clip (xtw) and chordae.When the second clip finally became free, it was removed from the anatomy.One gripper was detached from the broken gripper line attached to the mandrel and the other had chordae wrapped around it.There were no pieces visualized in the anatomy.There was also a possibly flail chordae created by the nt.Additional clips were not attempted due to the difficult anatomy.The mr remained at grade 4+.There were no adverse patient sequelae or clinically significant delay.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported break was confirmed via device analysis.The reported device damaged by another device (caused damage), difficult to remove (anatomy), difficult to remove (entanglement), and image resolution poor, could not be replicated in a testing environment.Additionally, the intact gripper line was observed to have a bend.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 complaints reported from this lot.Based on available information, the reported unspecified tissue injury associated with the chordae rupture/ flail, the reported/ observed break associated with the gripper line break, and the observed deformation due to compressive stress associated with the intact gripper line bend, were due to the removal of the clip from entanglement.The reported device damaged by another device (caused damage) associated with the clip interacting with a previously implanted clip was due to the entanglement.The cause of the reported difficult to remove (anatomy) associated with the entanglement with chordae, and the reported difficult to remove (entanglement) associated with the entanglement with a previously implanted clip, could not be determined.The cause of the reported mitral valve insufficiency/ regurgitation (unchanged mr) associated with mr remaining at pre-procedural baseline could not be determined.The reported image resolution poor was associated with difficult visualization due to anatomy.The reported patient effects of tissue injury and mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17921230
• MDR Text Key: 325505132
• Report Number: 2135147-2023-04476
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: 05415067037367
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 30607A1067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• 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: MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 64 KG