MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0601-XTR

Device Problems Leak/Splash (1354); Activation, Positioning or Separation Problem (2906)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

The other additional mitraclip referenced is being filed under a separate medwatch report number.Exemption number e2019001.The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed for a leak.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3+.It was noted that the tricuspid was successfully treated prior to the mitraclip procedure.During preparation of a clip delivery system (cds 90620u189), the cap of the lock line was too tight, and it would not come off.Forceps were used to remove the cap; however, when the cap was placed back on, fluid was leaking from the cap.The cds was not used in the patient, and another cds was prepared to complete the procedure.The second cds (90709u178) was advanced to the mitral valve, and the clip grasped the leaflets fine.However, the clip opened while locked when establishing final arm angle (efaa).Performed efaa again, and it was successful.Then moved forward with the deployment process.The lock line was removed, but then the clip opened while locked.Performed efaa again, and it passed.The clip was deployed.Another clip was deployed to further reduce mr.Two clips were implanted, reducing mr to 1+.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 this event.Additionally, a review of the complaint history did not identify any similar incidents from the reported lot.All available information was investigated and without the device to analyze, a definite cause for the reported leak and activation, positioning or separation problem could not be determined.There is no indication of product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9181258
• MDR Text Key: 172462863
• Report Number: 2024168-2019-12548
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2020
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 90620U189
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR