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

Catalog Number CDS0502

Device Problems Improper or Incorrect Procedure or Method (2017); Incomplete Coaptation (2507); Difficult or Delayed Activation (2577); Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

Patient Problems Mitral Regurgitation (1964); Neurological Deficit/Dysfunction (1982)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The clip was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The mitraclip delivery system (81006u184) referenced is filed under a separate medwatch report.

Event Description

This is filed for difficult deployment, clip movement, and single leaflet device attachment (slda) requiring surgical intervention (80914u183).It was reported that on (b)(6) 2019, the patient underwent a mitraclip procedure, treating grade 4 degenerative mitral regurgitation (mr).The 1st clip delivery system (cds-80914u183) was advanced, grasped the leaflets and mr was noted to be 1-2+.Deployment was initiated; however, the clip was difficult to deploy.The delivery catheter (dc) handle was pulled before the actuator knob was pulled.Troubleshooting was performed, and the clip was finally deployed, but clip movement was noted, and mr increased to 3-4+.A 2nd clip (80906u141) was advanced, with the intent to stabilize the clip movement and reduce mr.The movement of the 1st clip did not allow the 2nd clip to be deployed as close to the 1st clip as was intended, but the clip was deployed without issue, reducing mr to grade 3.A 3rd clip (81006u184) was advanced to implant on the medial side of the 1st implanted clip.Visualization was difficult, due to the movement of the 1st clip, so the grasp could not be assessed; however, mr was not reduced and the movement of the 1st clip was not improved.Blood pressure decreased, and a vasopressor was administered, stabilizing the patient.During positioning attempts, the clip became caught with the 1st clip, detaching it from the anterior leaflet (slda).Mr increased to 4+ and the patient was taken to emergency surgical mitral valve replacement.Both implanted clips were explanted and the mitral valve was replaced.The patient remains hospitalized and neurological status/level of consciousness is undetermined.There was no additional information provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: the device was received and investigated.The reported issues could not be tested as the clip was returned detached from the clip delivery system (cds).A review of the lot history record identified no manufacturing nonconformities issued to the reported that would have contributed to this event.Additionally, a review of the complaint history identified no lot specific product issue.The patient effect of mitral regurgitation (mr) as listed in the mitraclip system electronic instructions for use (ifu) is a known possible complication associated with mitraclip procedures.It should be noted that the ifu states to release the delivery catheter (dc) fastener then retract the actuator knob approximately 0.5 cm after it is fully unthreaded.The ifu deviation contributed to the difficulty deploying the clip.All available information was investigated and the reported difficult to deploy the clip was due to use error.The reported single leaflet device attachment (slda) was due to the reported dislodgement of device component and is due to procedural circumstances.The reported partial clip movement appears related to procedural circumstances as post dc shaft detachment, the clip partially moved.The reported device damaged by another device was due to procedural circumstances.Worsening mr was due to slda and a definitive cause for neurological deficit could not be determined.There is no indication of product quality issue with respect to manufacture, design or labeling.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, 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: 8484191
• MDR Text Key: 140951202
• Report Number: 2024168-2019-02656
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

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: 09/15/2019
• Device Catalogue Number: CDS0502
• Device Lot Number: 80914U183
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER3RD CDS (81006U184); STEERABLE GUIDE CATHETER3RD CDS (81006U184)
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 87 YR
• Patient Weight: 40