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); Improper or Incorrect Procedure or Method (2017); Incomplete Coaptation (2507); Device Damaged by Another Device (2915)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tissue Damage (2104)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: steerable guide catheter, 1 implanted mitraclip, 1 clip delivery system.Although the 3rd mitraclip clip arms were not confirmed to be perpendicular to the line of coaptation; this clip was eventually implanted lateral to the 2nd slda mitraclip.Post procedure, the mr was grade 4+, worse than pre-procedure mr.The first implanted mitraclip remained stable and well seated.The procedure ended and the patient was discharged to hospice.There was no additional information provided regarding this issue.Reported device code -failure to follow steps/instructions.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional, relevant information.The two other mitraclips are filed in separated medwatch reports.

Event Description

This report is filed on the second clip delivery system (cds 71103u165).The clip detached from one leaflet and remains attached to the other leaflet.Tissue damage and hypotension occurred.It was reported that this was a mitraclip procedure treating degenerative mitral regurgitation (mr) grade 4 with anterior 2 leaflet flail.One mitraclip (71027u288) was implanted without issue.A 2nd clip delivery system (cds 71103u165) was advanced to the mitral valve.During advancement, this cds interacted with the first implanted mitraclip.The second cds had a poor grasp on the leaflets and, against advice, clip deployment was initiated.While flossing the gripper line without resistance, clip movement was noted on the leaflet.Once deployed, the posterior leaflet came out of the clip (single leaflet device attachment-slda).The mr increased and tissue damage was suspected.Blood pressure dropped and medications were provided.As treatment for the slda, a third clip delivery system (cds 71103u166) was advanced to the mitral valve.During positioning, the 3rd cds interacted with subvalvular tissue.The 3rd cds could be retracted into the left atrium, pulling the mitral valve upward.This 3rd cds caught the 2nd implanted mitraclip, pushing the 2nd implanted mitraclip on top of the 1st implanted mitraclip resulting in severe tissue damage and no leaflet coaptation.The 1st and 2nd implanted mitraclips were now formed as an upside-down t, both stacked on each other.More tissue damage was suspected with even worsening mr.

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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on the information provided, the reported partial clip movement (failure to adhere or bond) and slda appear to be primarily due to the user error of clip deployment despite an unsatisfactory leaflet insertion.Additionally, patient morphology/pathology of a leaflet flail may also have contributed to the reported partial clip movement and slda.Device damaged by another (damaged) appears to be due to a combination of patient morphology/pathology and user technique/procedural circumstances.The reported tissue damage appears to be a result of procedural circumstances and due to device damaged by another and slda.The reported hypotension was likely a cascading effect of tissue damage.The reported patient effects of mitral valve injury (tissue damage) and hypotension, as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.It should be noted that in the mitraclip ifu instructs the user to use echocardiographic imaging to verify valve function, satisfactory coaptation, and insertion of both leaflets by observation of leaflet immobilization, single or multiple valve orifice(s), limited leaflet mobility relative to the tips of both clip arms, and adequate mr reduction.As it was reported that the leaflet insertion was not satisfactory prior to deployment, this likely resulted in the partial clip movement and single leaflet device attachment (slda).Based on the information reviewed, 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
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7379943
• MDR Text Key: 103776628
• Report Number: 2024168-2018-02264
• Device Sequence Number: 1
• Product Code: NKM
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

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: 11/04/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71103U165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 06/04/2018
• Supplement Dates FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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): Required Intervention
• Patient Age: 91 YR
• Patient Weight: 52