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

Catalog Number CDS0602-XTR

Device Problems Failure To Adhere Or Bond (1031); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The mitraclip xtr is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

This is filed to report clip opening after deployment and clip movement.It was reported that this was a mitraclip procedure to treat function mitral regurgitation (mr) with a grade of 3.The clip was placed on the anterior 2/posterior 2 (a2/p2) leaflet segment.The clip was closed completely and was deployed.After clip deployment, it was noted that the clip had opened a bit and may have moved on the leaflet.Both leaflets were still within the clip, but an increase in mr was noted.A second clip was implanted medial to the first and the mr was reduced to grade 1.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: device not available for evaluation.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 did not identify a lot specific product quality issue.All available information was investigated and a definitive cause for the reported mechanical issue (clip open - locked) could not be determined; however, the reported failure to adhere or bond appears to be due to mechanical issue as post deployment, the clip opened slightly and partial clip movement was suspected.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: after the clip was deployed, mitral regurgitation (mr) was reduced; however, when the clip moved on the leaflet, mr increased back to grade 3.No additional information was provided.

• Brand Name: MITRACLIP XTR DELIVERY SYSTEM
• 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: 7517085
• MDR Text Key: 108350272
• Report Number: 2024168-2018-03621
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

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: 01/17/2019
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 80116U261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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 Outcome(s): Required Intervention