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

Model Number N/A

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

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

Event Date 08/25/2022

Event Type  Injury  

Event Description

This is filed to report air in the valve and clip introducer break.It was reported that on (b)(6) 2022, a mitraclip procedure was performed to treat mixed mitral regurgitation with grade of 4+.Upon inserting the clip delivery system (cds, 20428r369) into the guide, air appeared in the valve of the guide.They started aspirating and removed the cds and introducer.The stopcock was noticed to be barely attached and then the plastic part fell off.Air was aspirated from the guide with no adverse patient effects.Another clip (20214r102) was prepped and advanced to the mitral valve.Imaging was difficult, causing the clip to get caught on the anterior leaflet and sub-valvular structure.Standard troubleshooting was performed to free the clip.However, the clip was not completely freed as it was believed there was some chordal involvement still making grasping difficult.The clip was able to be implanted and remained stable on the valve.Another clip was also implanted with no reported issue, reducing mr to grade 3.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

The device was not returned for analysis.The reported broken clip introducer appears to be related to a potential product issue; therefore, this complaint was added to open exception (issue) (b)(4) on 27-sep-2022 to evaluate whether a product quality issue exists.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 other complaints reported from this lot.The investigation determined the reported leak appears to be related to reported broken clip introducer.The broken clip introducer appears to be related to a potential product issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.The reported unexpected medical intervention was a result of case-specific circumstance.

• 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: 15447128
• MDR Text Key: 302285784
• Report Number: 2135147-2022-01242
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: N/A
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 20428R369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male