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 Problem Tricuspid Valve Stenosis (2113)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient anatomy.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Exemption number (b)(4) 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.Na.

Event Description

This is filed for an increase in mean pressure gradient to 10mm hg, one day post procedure.It was reported that this was a mitraclip procedure to treat tricuspid regurgitation (tr) with a grade of 4 with thickened leaflets and a posterior prolapse.Two mitraclips were implanted, successfully reducing tr to 1 and a gradient of 4-5 mmhg.There was no clinically significant delay in the procedure.One day post procedure, the gradient had increased to 10 mmhg.The patient had no symptoms and was discharged as planned.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.It was also 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 states: ¿the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation¿.Based on the information reviewed, the reported patient selection (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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.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.Mfr site - contact office first and last name.

• 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: 8796118
• MDR Text Key: 151223805
• Report Number: 2024168-2019-10102
• 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: 09/09/2019

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: 05/10/2020
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 90510U287
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CDS0601-XTR; CDS0601-XTR
• Patient Outcome(s): Other