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

Model Number CDS0701-XTW

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problems Air Embolism (1697); Cardiac Enzyme Elevation (1838)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report a leak, and medical intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation with an (mr) grade of 4+ after the initial insertion of the clip delivery system (cds) into the steerable guide catheter (sgc), it was determined that the transseptal puncture was too low.The cds and sgc were removed, and an alternate transseptal puncture was used.Then shortly after the clip introducer was re-inserted into the sgc the patient had enzyme elevations for 6-10 seconds and a small air was noted.A leak in the clip introducer was suspected.An attempt was made to aspirate the air, but when the coronary angiogram was performed, the air was no longer visible.The procedure continued, and the clip was successfully deployed.One clip was implanted, reducing mr to 1-2.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.All available information was investigated, and a conclusive cause for the reported leak/splash cannot be determined.It should be noted that the mitraclip instructions for use (ifu), warns the user: do not re-use the clip delivery system (cd) after removal.Replace the cds with a new device.The improper or incorrect procedure or method is associated with re-using/re-inserting the cds after removal.In this case, as it cannot be confirmed whether the user error of re-inserting the device led to the reported issue.The air embolism resulting in cardiac enzyme elevation appears to be related to the procedural circumstances and due to the leak.The reported patient effect of emboli (air) is listed in the mitraclip ifu as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 10138145
• MDR Text Key: 194634768
• Report Number: 2024168-2020-04870
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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: 06/17/2020

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 Expiration Date: 12/03/2020
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 91205U122
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 06/12/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 68