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

Model Number CDS0701-NTW

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

Patient Problems Stroke/CVA (1770); Thrombosis (2100); Pericardial Effusion (3271)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

This is being filed to report after the procedure, the patient experienced a pericardial effusion, blood clot and stroke.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with grade 3-4.The clip delivery system (cds) was advanced and the cds got stuck on the coumadin ridge; therefore, the stabilizer was pulled back.The cds handle was retracted and added posterior guide torque which created room to allow the cds to get below the coumadin ridge.It was noted that the cds was difficult to position due to the anatomy and challenging imaging.The clip was placed in position and the clip was implanted, reducing mr to <1.When the steerable guide catheter was removed, a pericardial effusion was noted.The physician had difficulty stating where the effusion had originated but it appeared to be on the posterior wall of the heart.The pericardial effusion stabilized on its own.The patient was kept overnight for observation.The next day, the patient developed a blood clot in the carotid artery and had a stroke.The patient was treated with blood thinners and was sent to another hospital for treatment of the stroke.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 issue.All available information was investigated and a cause for the difficult to remove (clip becoming caught in anatomy) cannot be determined.It is possible that it was, due to patient/procedural conditions.However, this cannot be confirmed.The difficult or delayed positioning was reported, to be due to the anatomy and challenging imaging.The poor image resolution is related to imaging being challenging, and thus related to procedural circumstances.Additionally, a cause for the reported pericardial effusion and thrombosis resulting in cerebrovascular accident cannot be determined.However, cerebrovascular accident, pericardial effusion and thrombosis are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The treatment with medication and hospitalization were a result of case-specific circumstances.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: 11109441
• MDR Text Key: 224817338
• Report Number: 2024168-2021-00019
• 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: 02/19/2021

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: 06/18/2021
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 00618U127
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 67