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

Model Number CDS0701-NTW

Device Problems Improper or Incorrect Procedure or Method (2017); Incomplete Coaptation (2507)

Patient Problem Pulmonary Embolism (1498)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other clip delivery system mentioned is being filed under a separate medwatch report #.

Event Description

This is filed on the first implanted clip with the single leaflet attachment.It was reported that on (b)(6) 2021 the patient with mixed etiology mitral regurgitation (mr) grade 4 underwent the mitraclip procedure.Imaging was a challenge because of shadows created by the rotation of the heart.After the first mitraclip was implanted, a single leaflet device attachment (slda) was noted.The anterior leaflet was no longer inside the clip.In the physician's opinion, the slda was due to the patient anatomy.A second clip delivery system (cds) was prepared and inserted according to the device instructions for use, but the anterior gripper (non-dimpled) was not actuating when the lever was engaged.Trouble-shooting steps were performed such as cycling the grippers, locking the clip, and closing it, but these did not work.This cds was removed, undeployed, from the patient.Another cds was inserted and worked fine.The procedure was completed with mr grade 1 and two implanted mitraclips.The next day, (b)(6) 2021, the patient was reportedly in good condition and was ready to be discharged from the hospital, but the patient expired.The cause of death was a pulmonary embolus.An echocardiogram done earlier that day showed the clips were stable and there was no pericardial effusion.The mitraclip is not thought to be related to the patient death.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 did not indicate a lot-specific product issue.All information was investigated and the reported slda per the physician is related to patient morphology/pathology (rotated heart).The poor image resolution was related to the shadows created by the rotation of the heart and thus related to patient and procedural circumstances.The reported user error is associated with the use of an expired clip delivery system (cds) that was used during the mitraclip procedure.The unexpected medical intervention was a result of case-specific circumstances.It was noted that the slda clip was implanted four days past the expiration date.In this case, there were no issues identified due to the use of an expired device.Although there was a need to implant an additional clip (unexpected medical intervention) and the patient expired one day post-procedure, these patient effects were unrelated to the use of an expired device.It should be noted that the mitraclip instructions for use, warns: "do not use the mitraclip® g4 system after the ¿use by¿ date stated on the package label.Use of expired, reused, or re-sterilized devices may result in infection".In this case, the user error did not contribute to the reported event.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: 12313191
• MDR Text Key: 266229448
• Report Number: 2024168-2021-07098
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• 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: 10/01/2021

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: 07/23/2021
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 00724U190
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/01/2021
• 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: 85 YR