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

Catalog Number CDS0602-XTR

Device Problems Off-Label Use (1494); Expulsion (2933)

Patient Problems Embolism (1829); Tissue Damage (2104); Tricuspid Regurgitation (2112)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on this available information, a cause for the reported complete clip detachment (ccd) could not be determined.The reported tissue damage, embolism, and worsening tricuspid regurgitation (tr) were likely results of the ccd.The reported patient effects of tissue damage, embolism, and worsening tr are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.It should be noted that, per the intended use section of the mitraclip instructions for use (ifu), it states: 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; however, it could not be determined if the off-label use of using the mitraclip on the tricuspid valve caused or contributed to the reported clip expulsion.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is being filed to report the clip detachment and embolism.It was reported that the initial mitraclip procedure was performed on (b)(6) 2020, to treat degenerative mitral regurgitation (mr) with a grade of 4+.One clip was implanted, reducing mr to 1+.The procedure was then changed to treat the tricuspid regurgitation (tr) with a grade of 2-3+.One clip was implanted, reducing tr to 1-2+.On (b)(6) 2020, the patient returned for a follow up transthoracic echocardiogram (tte) where it was noted the clip implanted in the tricuspid had detached and was located on the atrial septum wall in the right atrium (ra).Damage was noted to the septal leaflet and the tr increased to 4.The patient was sent for open heart surgery to remove the detached clip and perform tricuspid valve replacement.No additional information was provided.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11012174
• MDR Text Key: 221552521
• Report Number: 2024168-2020-10515
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2020

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: 05/04/2021
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 00501U105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 52