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); Bent (1059); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The customer reported the clip was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The additional mitraclip devices referenced are filed under separate medwatch reports.

Event Description

This is filed to report the unintended movement of the clip delivery system (cds 71030u127).It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation with an mr grade of 4.The patient's baseline mean pressure gradient was 3mmhg.The first clip was implanted successfully.The second clip delivery system (cds 71030u127) was advanced to the mitral valve to further reduce mr.While advancing the cds handle, the cds took a medial dive and then an anterior dive.When the clip was positioned at the valve, the leaflets could not be grasped because the clip rotated.It was observed that the m-knob was at the 6-7 o'clock position and the cds was curved more than 90 degrees.It was commented that this may have caused a set in the shaft resulting in the observed anterior/medial diving.The clip was not implanted and was replaced.During preparation of the second cds (80123u141), when loading the clip into the clip introducer (ci), the clip arm got caught on the ci and the ci tore.The device was not used and was replaced.The next cds (71026u288) was advanced to the mitral valve and the clip was implanted successfully; however, after deployment the mean pressure gradient increased to 6mmhg.No further clips were used.Two clips were implanted reducing mr to 2.There was no clinically significant delay during the procedure.The patient is stable.No additional information was 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 that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.It was reported that the user curved the clip delivery system (cds) more than 90 degrees.It should be noted that in the mitraclip instructions for use, states: do not deflect the sleeve tip more than 90 degrees as device damage may occur.The reported bent shaft is a result of the user error.The reported difficulty to position the delivery catheter (dc) shaft was a secondary effect of the bent shaft.The cds being curved more than 90 degrees appears to have contributed to the reported difficult to position (clip rotation while attempting to grasp).The failure to difficulty grasping is a secondary effect of the difficult to position (clip rotation).Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

• 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: 7592833
• MDR Text Key: 111159781
• Report Number: 2024168-2018-04410
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71030U127
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETERIMPLANTED MITRACLIP(X1)
• Patient Age: 84 YR
• Patient Weight: 67