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

Model Number CDS0601-NTR

Device Problems Failure to Advance (2524); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

The reported device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities from this lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and the reported failure to advance resulting frayed clip cover appears to be related to patient morphology/pathology in conjunction with user technique/procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the frayed clip cover.It was reported that this was a mitraclip procedure to treat grade 4+ functional mitral regurgitation (mr).The steerable guide catheter was advanced and the mitraclip delivery system (cds), was inserted.The transseptal puncture was too inferior, to position the clip above the valve.The clip was not implanted and the cds and sgc were removed.After removal of the cds, it was observed the clip cover was frayed.The cds was no longer used.A new transseptal puncture was performed.The same sgc was used, but it failed to cross the septum.The septum was further dilated with a 8mm and 12mm balloon.With difficulty due to the anatomy, the same sgc was advanced to the appropriate position along with a new ntr clip to successfully complete the procedure.One clip was implanted, reducing mr to 1+.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MITRACLIP NTR DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10011952
• MDR Text Key: 191836718
• Report Number: 2024168-2020-04002
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 91211U254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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
• Patient Age: 85 YR