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

Model Number CDS0601-XTR

Device Problems Off-Label Use (1494); Failure to Advance (2524)

Patient Problem Tissue Damage (2104)

Event Date 06/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other complaints reported from this lot.The reported patient effect of tissue damage 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 mitraclip system, ifu, the device 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.Based on the available information, a definitive cause for the reported failure to advance and poor imaging could not be determined.The reported patient effect of tissue damage appears to be due to procedural circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

This is filed to report tissue damage.It was reported that this was a mitraclip procedure performed to treat tricuspid regurgitation (tr) with a grade of 4.Imaging was challenging.The first clip was implanted successfully.To further reduce tr, a second clip was advanced.However, the clip could not be positioned below the valve; therefore no grasping attempts were made.The clip was not implanted.When the clip was removed and examined, tissue was observed on the clip.It is possible, that at some point one clip arm went under the valve when echo was trying to optimize imaging, resulting in tissue damage.No additional clips were implanted.Tr remained at 4.The patient remained stable.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: 10206718
• MDR Text Key: 197108485
• Report Number: 2024168-2020-05399
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2020

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: 11/24/2020
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 91122U468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2019
• 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
• Patient Outcome(s): Other