MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0501

Device Problems Failure To Adhere Or Bond (1031); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem Tissue Damage (2104)

Event Date 03/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the clip delivery system was discarded.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 torn chordae in the right ventricle.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).One mitraclip was successfully implanted reducing mr to grade 2.The focus then went to treating the tricuspid regurgitation (tr) grade 4 with a mitraclip, but imaging was a challenge due to inexperience of the echocardiographer and the implanting physician.The tricuspid leaflets were unable to be grasped with the clip delivery system (cds).When the clip was in an open position, the cds was inadvertently advanced below the tricuspid valve and became entangled in the tricuspid chordae.The cds was successfully removed from the chordae with troubleshooting maneuvers; however, a chord was suspected to have become torn in the process.Additional attempts to grasp the tricuspid leaflets were made, but the attempts were unsuccessful.The tricuspid case was completed with zero clips implanted.The untreated tr remained grade 4.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Review of the complaint history did not indicate a lot-specific quality issue.The reported patient effect of torn chordae (tissue damage) as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported failure to adhere/bond (difficulty grasping the leaflets) was due to a combination on procedural circumstances (visualization) and user technique (inexperience of the echocardiographer and the implanting physician).The difficulty removing the device due to interaction with the chordae and was related to the user technique (user inadvertently advanced below the tricuspid valve and became entangled in the tricuspid chordae).The reported patient effect of tissue damage was a result of procedural circumstances (troubleshooting maneuvers used to remove the clip from the chordae).It should be noted that the mitraclip nt instructions for use states: the mitraclip nt system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (mr greater than 3+).As it was reported that the mitraclip device was used on the tricuspid valve, this incident is considered an off-label use of the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7375858
• MDR Text Key: 103648642
• Report Number: 2024168-2018-02241
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

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: 08/29/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70828U152
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 06/26/2018
• Supplement Dates FDA Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Weight: 89