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

Model Number CDS0601-XTR

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problems Tissue Damage (2104); Atrial Perforation (2511)

Event Date 02/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report unintended movement, tissue damage and atrial perforation it was reported that this was a mitraclip procedure to treat tricuspid regurgitation (tr) with a grade of 5.Prior to treat the tricuspid valve, two clips were successfully implanted in the mitral valve without issues.To treat the tricuspid valve, the sgc was retracted into the right atrium (ra) and an xtr clip delivery system (cds) (90828u269) was inserted into the steerable guide catheter (sgc).However, it was noted to be purposely mis keyed 180 degrees.After the cds was advanced, a-knob was applied, but the cds moved in an unintended direction and entered into the left atrium (la), even though the sgc was in the ra, causing a clinically significant delay in the procedure.The cds was attempted to be retracted into the sgc but was unable to cross the septum.It was then noted through fluoroscopy, one of the clip arms was slightly open.The physician feared the clip was no longer attached to the cds.Therefore, the sgc was advanced back into the la.The physician then noticed that the clip was still attached.The clip was able to be fully closed and was retracted into the sgc.The cds was removed from the patient; however, at this time, tissue was noted to be attached to the grippers.The cds was reinserted and successfully deployed in the tricuspid valve.After the clip was deployed, it was noted that the shunt was larger than normal.However, no treatment was provided to treat the shunt.Tr reduced to a grade of 2-3.Imaging was noted to be difficult due to the anatomy.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 this event.Additionally, a review of the complaint history identified no similar incident reported from this lot.It should be noted that in the instruction for use mitraclip system manual instruction for use (ifu) stated: ¿align the longitudinal alignment marker on the sleeve shaft with the alignment marker on the guide hemostasis valve¿.It was reported that it clip delivery system (cds) was miss keyed with the steerable guide catheter.The investigation determined the reported improper or incorrect procedure or method was due to user error of deviating from ifu.Furthermore, the reported unintended movement appears to be due to the user error.The reported difficult to remove was a result of reported unintended movement.The reported unintended movement (clip open locked) and patient effects of tissue damage and atrial perforation appear to be due to procedural circumstances.The reported patient effects of tissue damage and atrial perforation are listed in the mitraclip ntr/xtr system ifu as known possible complications associated with mitraclip procedure.The ifu also states: ¿the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation." the reported off-label use was related to the use of the mitraclip device on the tricuspid valve.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 9817840
• MDR Text Key: 184269303
• Report Number: 2024168-2020-02251
• 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: 04/06/2020

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: 08/28/2020
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 90828U269
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other