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

Catalog Number CDS0601-XTR

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

Patient Problems Arrhythmia (1721); Bradycardia (1751); Tricuspid Valve Stenosis (2113)

Event Date 08/28/2019

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.

Event Description

This is being filed to report post procedure, tricuspid stenosis occurred requiring medical intervention.It was reported that this was a mitraclip procedure to treat tricuspid regurgitation (tr) with an tr grade of 4+.Three clips were implanted reducing mr to less than 1.However, post procedure, the mean pressure gradient increased to 12 mmhg with heart rate of 60 bpm, bradycardia of 30-40 bpm and sinus pauses.Beta blocker (metoprolol) had to be stopped and heart rate gradually improved.A pacemaker was inserted to allow for the re-insertion of the metoprolol.The patient remained in the hospital and was stable and discharged on (b)(6) 2019.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It was reported that the procedure was used to treat tricuspid regurgitation.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¿.Based on the information reviewed, a definitive cause for the reported patient effect of tricuspid stenosis could not be determined.The reported arrhythmia and bradycardia appears to be due to reported tricuspid stenosis.The reported off label use was associated with the use of the mitraclip device on the tricuspid valve, which is considered an off-label use of the device.Additionally, the reported patient effects of arrhythmia, bradycardia and tricuspid stenosis are listed in the mitraclip system ifu as known possible complications 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.Device code 1494 added.

• 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: 9134831
• MDR Text Key: 162323944
• Report Number: 2024168-2019-12195
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• 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: 11/12/2019

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: 03/01/2020
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 90301U207
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 11/01/2019
• Supplement Dates FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 68