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

Model Number CDS0701-NT

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); Tricuspid Valve Stenosis (2113)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

The other additional 2 mitraclips are being filed under a separate medwatch report number.The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.A definitive cause for the reported patient effect of tricuspid stenosis and thrombosis could not be determined.It should be noted that the intended use section of the mitraclip system, instruction for use states: ¿the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation.The reported off-label use appears to be related to the use of the mitraclip device on the tricuspid valve; however, it could not be determined if using the mitraclip on the tricuspid valve caused or contributed to the reported difficulties.The reported patient effects of tricuspid stenosis and thrombosis are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report thrombosis, stenosis, treatment with medication, and prolonged hospitalization.It was reported that this was a mitraclip procedure to treat functional tricuspid regurgitation (tr) with a grade 4.On (b)(6) 2020, three clips were implanted for off label-use, reducing tr to <1.The next day, imaging revealed thrombosis on the anterior septal region and possibly to the posterior septal region, indicating the thrombosis is across all three clips (00107u222, 91106u225, 91106u244).Additionally, the mean pressure gradient increased to 6mmhg.The stenosis was not treated since the patient did not experience any clinical symptoms.However, blood thinners were administered to the patient in an attempt to treat the thrombosis.The patient will remain hospitalized until the thrombosis is resolved.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, a definitive cause for the reported patient effect of tricuspid stenosis and thrombosis could not be determined.It was reported that the procedure was used to treat the tricuspid valve.It should be noted that the intended use section of the mitraclip system instruction for use (ifu) states: ¿the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation.Since, the device was used for a tricuspid valve procedure, this is considered as an off-label use of the device.However, it could not be determined if using the mitraclip on the tricuspid valve caused or contributed to the reported difficulties.The reported patient effect of thrombosis is listed in the mitraclip system ifu as a known possible complication associated with mitraclip procedures.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.Added a conclusion code removed statement, the reported patient effects of tricuspid stenosis and thrombosis are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9898425
• MDR Text Key: 188558630
• Report Number: 2024168-2020-03095
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• 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: 04/09/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2020
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 91106U244
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: 2 IMPLANTED MITRACLIPS
• Patient Outcome(s): Hospitalization; Other; Required Intervention