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); Difficult or Delayed Positioning (1157); Incomplete Coaptation (2507)

Patient Problems Mitral Regurgitation (1964); Tissue Damage (2104)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report the difficult clip deployment and single leaflet device attachment (slda).It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The first clip delivery system (cds 80202u219) was advanced to the mitral valve.The clip was positioned medial of a2p2.Grasping was noted to be difficult.During the deployment sequence, increased resistance was noted retracting the delivery catheter (dc) handle.The handle continued to be retracted, and clip deployment was achieved.After deployment, the clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).The mr increased to 4.It was also stated that both leaflets were jerked strongly after clip placement because of a large annulus.The posterior leaflet was completely inserted and may have applied force to the anterior leaflet causing the detachment.It was possible that there was leaflet damage; however, this was not confirmed.A second clip was placed on the lateral side of first clip with a residual mr grade of 2.The patient was stable post procedure; however, it was noted that the mr may be getting worse.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 identified no similar incidents reported from this lot.The reported patient effects of recurrent mitral regurgitation (mr) and mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.Procedural imaging was received and reviewed by an abbott vascular medical advisor who noted that a big force was applied to the clip delivery system (cds) handle to try to pull it back to deploy the clip.This movement displaced the whole valve toward the left atrium and most probably was the cause for the single leaflet device attachment (slda).The detachment from the anterior leaflet probably caused the tearing of the leaflet itself.All available information was investigated and the reported difficulty grasping appears to be related to patient morphology/pathology.The slda was a result of the challenging patient morphology/pathology combined with procedural conditions.A definitive cause for the reported difficulty to deploy the clip could not be determined.The reported tissue damage is a result of the slda and recurrent mr is a cascading effect of the slda and tissue damage.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
• 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: 7523159
• MDR Text Key: 108557949
• Report Number: 2024168-2018-03677
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

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: 02/05/2019
• Device Catalogue Number: CDS0502
• Device Lot Number: 80202U219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 51