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

Catalog Number CDS0602-XTR

Device Problems Difficult or Delayed Positioning (1157); Off-Label Use (1494); Incomplete Coaptation (2507)

Patient Problems Edema (1820); Tricuspid Regurgitation (2112); No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.Implant date: estimated.(b)(4).The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the single leaflet device attachment (slda).It was reported the mitraclip procedure was performed in (b)(6) 2020 to treat tricuspid regurgitation.One xtr clip was implanted.Approximately three months post procedure, echocardiogram was performed, and the clip was noted as detached from the anterior leaflet but remained attached to the septal leaflet, (slda).The patient is scheduled for a tricuspid clip re-intervention on (b)(6) 2020.No additional information was provided.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: one xtr clip was implanted on (b)(6) 2020.Imaging during grasping was poor due to the previously aortic valve intervention and previously implanted cardioband.Grasping was difficult, the leaflets were not clearly seen inside the clip.The clip was implanted and tricuspid regurgitation (tr) was reduced from 4 to 3-4.On (b)(6) 2020, the patient was hospitalized with lower extremity edema.Echocardiogram was performed confirming the single leaflet device attachment (slda) and tr increased to 4.A second procedure was performed on (b)(6) 2020.One clip was implanted, reducing tr to 3.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported patient effect of edema as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.It should be noted that, per the intended use section of the mitraclip system ifu, the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation.In this case, the device was used for a tricuspid valve procedure.It appears that the the off label use also contributed to the reported difficulty positioning as well as the slda.Based on the information reviewed, the single leaflet device attachment (slda) was due to procedural conditions.The reported poor imaging resolution was caused by challenging patient anatomy.The difficulty positioning (leaflet grasping) appears to be related to combination of procedural conditions and challenging patient anatomy.The off label use was related to the use of the mitraclip device on the tricuspid valve.The tricuspid regurgitation (tr) appears to be due to the procedural conditions of the slda.A cause for the edema could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.B3: date of event.D6: implant date.G4 date received by manufacturer, on initial report should have been (b)(6) 2020.H1: type of report.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10054347
• MDR Text Key: 191993378
• Report Number: 2024168-2020-04290
• Device Sequence Number: 1
• Product Code: NKM
• 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: 06/11/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 91207U264
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: 05/20/2020
• Supplement Dates FDA Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention