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

Model Number CDS0601-NTR

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional two devices referenced in b5 are filed under separate medwatch report numbers.Na.

Event Description

This is being filed to report the clip did not perform as intended.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.During preparation of the clip delivery system (cds) it failed to establish final arm angle (efaa) and the clip jumped open; therefore the cds was not used.Two additional cds were inserted into the patient however per the physician, they did not perform as intended therefore the clips were not implanted and the cds removed.Three clips were implanted, reducing mr to 3-4.There was no clinically significant delay in the procedure and no adverse patient effects.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 resulted in this event.Additionally, a review of the complaint history identified no other similar complaints reported from this lot.All available information was investigated, and a conclusive cause for the reported activation positioning and separation issue could not be determined in this complaint.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11132325
• MDR Text Key: 225560951
• Report Number: 2024168-2021-00208
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2021
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 00213U155
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER.; STEERABLE GUIDE CATHETER
• Patient Age: 73 YR
• Patient Weight: 91