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

Catalog Number CDS0502

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

Patient Problem Tricuspid Regurgitation (2112)

Event Date 11/28/2017

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).Indication for use (tricuspid valve).The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the partial clip movement.It was reported that this was a mitraclip procedure performed to treat tricuspid valve regurgitation (tr) with a tr grade of 4.Echo visualization was difficult.Three clips (70831u232, 70724u146, and 70731u245) were implanted, in the tricuspid valve.Grasping and leaflet insertion assessment was complicated with the three clips due to difficult visualization conditions.The leaflets were eventually grasped, tr remained unchanged; due to the anatomy (severe coaptation defect).It was noted that one clip partially detached from the leaflet.(it is not known which clip).The third clip was implanted to stabilize the implanted clip.Tr remained at 4.The patient is in stable condition.No additional treatment is planned for the patient.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).A review of the lot history record and complaint history was performed for all three clip delivery system (cds) devices used during the procedure: part and lot number: cds0502/70831u2/32, date of manufacture: 31-aug-2017, expiration date: 31-aug-2018, udi# (b)(4), part and lot number: cds0502/70724u1/46, date of manufacture: 25-jul-2017, expiration date: 25-jul-2018, unique device identifier (udi) number: (b)(4), part and lot number: cds0502/70731u2/45, date of manufacture: 31-jul-2017, expiration date: 31-jul-2018, udi# (b)(4).The devices were not returned for analysis.A review of the lot history record and complaint history was performed for all the devices used during the procedure, as the specific device associated with the partial clip movement could not be determined.A review of the lot history records identified no manufacturing nonconformities issued to the reported lots that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and the reported failure to adhere or bond to the leaflets associated with partial clip movement and difficulty grasping appears to be due to a combination of patient morphology/pathology and procedural circumstances of challenges associated with echo imaging.The reported poor image resolution issue was associated with the difficult visualization of echo imaging due to shadowing from the artificial mitral valve.The reported unchanged tricuspid regurgitation was due to the combination of the patient anatomy and procedural circumstances of partial clip movement.It should be noted that the mitraclip nt instructions for use states that the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the devices.

• 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: 7134837
• MDR Text Key: 95382915
• Report Number: 2024168-2017-09977
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

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 Catalogue Number: CDS0502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 03/06/2018
• Supplement Dates FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: STEERABLE GUIDE CATHETER, CLIP DELIVERY SYSTEM(X2)
• Patient Outcome(s): Required Intervention