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

Catalog Number CDS0501

Device Problems Unstable (1667); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip was not implanted and the cds was removed.Two clips were implanted, and the mr remained at 3-4.No additional intervention was performed and the patient will be monitored.No additional information was provided.Evaluation summary: the device was returned and investigated.The reported inability to open the clip was not confirmed; however, an unstable release crimper was noted.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The investigation determined the reported inability to open the clip appears to be related to user technique due to the user not retracting the lock lever sufficiently.The identified loose release crimper was due to multiple manipulations of the device during the procedure and post-procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Cds 80529u285 is filed under mfr#: 2024168-2018-06412.

Event Description

This event is filed for loose release crimper.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.The first clip delivery system (cds 80511u289) was advanced to the left atrium, but the clip would not open.Troubleshooting maneuvers were performed, but were unsuccessful.The cds was removed with the clip.Outside the patient anatomy, an attempt was made to open the clip again, and the clip opened successfully.It was thought that possibly the lock lever had not been pulled back sufficiently when in the anatomy.A new cds was then advanced to the mitral valve and this was the first clip implanted.The next cds (80529u285) was advanced.Visualization was difficult due to the previously implanted clip.The deployment sequence was started; however, when the actuator knob was pulled, the clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), and it appeared that the clip had opened approximately 60-70 degrees.An additional cds was advanced to stabilize the slda clip; however, during positioning, it appeared that the slda clip was moved on the anterior leaflet.The physician felt uncomfortable deploying the last clip for fear of causing the slda clip to fully detach from the other leaflet.Returned device analysis noted that the release crimper was returned loose from the crimping cam.No additional information was provided.

• 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: 7936340
• MDR Text Key: 125127632
• Report Number: 2024168-2018-07690
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80511U289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• 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
• Patient Age: 84 YR
• Patient Weight: 90