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); Incomplete Coaptation (2507)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2018

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 relevant information.

Event Description

This is filed to report the single leaflet device attachment (slda).It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.The first clip delivery system (cds)(70629u143) was advanced to the mitral valve and after several attempts to grasp the leaflets, the clip was deployed.The mr was reduced to 2.While preparing the second cds(70629u145), it was noted the first clip detached from the posterior leaflet and remained attached to the anterior leaflet (slda).The mr returned to 3.The second clip was implanted medial of the first implanted clip to treat the mr and stabilize the first clip, reducing the mr to 2.A third clip was implanted lateral, reducing the mr to 1.The patient left cath lab stable.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 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/ bond (difficult grasping the leaflet) and single leaflet device attachment (slda) in this incident appears to be related to patient morphology/challenging anatomy (pre- existing thin posterior mitral leaflet).The reported poor image resolution is related to the difficulty in visualization during the procedure as it was not possible to show both leaflets on the clip arms at one time.It was needed to rotate the echo probe to show them one by one.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 7304242
• MDR Text Key: 101232447
• Report Number: 2024168-2018-01447
• 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: 05/29/2018

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: 06/29/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 70629U143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 05/23/2018
• Supplement Dates FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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