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

Catalog Number CDS0502

Device Problem Difficult to Open or Close (2921)

Patient Problem Diminished Pulse Pressure (2606)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device is filed under a separate medwatch report number.

Event Description

This is filed to report the clip did not open and the procedure was prolonged (00402u266).It was reported that this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (mr).The first clip (00210u143) was placed in a2/p2.After checking the final arm angle when attempting to remove the lock line, both ends became tangled.Scissors were used to cut the tangled portion.When attempting to remove the lock line, it was observed, that the clip was open at 60 degrees.The clip was re-closed following the troubleshooting process.The clip was confirmed to stay closed and was implanted, mr reduced to 1-2.To further reduce mr, a second clip (00402u266) was advanced.When attempting to open the clip in the left atrium, the clip did not open.After repeated troubleshooting, the clip could not be opened and was removed.The patient's circulation was inadequate due to the prolonged anesthesia; therefore, the procedure was aborted.Mr was reduced to 1-2.No additional information was provided.

Manufacturer Narrative

The device was returned and investigated.The reported inability to open the clip was not confirmed via returned device analysis.However, it was observed that the clip was difficult to open and there was a slack in the lock line in the lock lever.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 did not indicate a lot-specific quality issue.The reported patient effect of diminished pulse, as listed in the mitraclip nt system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.The investigation determined the clip actuation issues appear to be related to the observed slack in the lock line; however, a cause for how the slack became present could not be definitively determined.The diminished pulse appears to be related to procedural conditions.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10511650
• MDR Text Key: 206296956
• Report Number: 2024168-2020-07509
• Device Sequence Number: 1
• Product Code: NKM
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

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: 04/03/2021
• Device Catalogue Number: CDS0502
• Device Lot Number: 00402U266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 34