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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The steerable guide catheter referenced was filed under a separate medwatch report number as 335628-1-1.The device was returned for analysis and abbott vascular (av) confirmed the reported clip actuation issue.The reported failure to adhere or bond to leaflets could not be replicated in a testing environment, as it was related to procedural condition.Returned device analysis identified a loosened release crimper.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 did not indicate a lot-specific quality issue.The potential product issue will be addressed per internal operating procedures.Av will continue to trend the performance of these devices.

Event Description

This is filed to report the loose release crimper that was noted during device analysis.It was reported that this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (mr).After the clip delivery system (cds) was advanced to the left atrium and positioned on the mitral valve, two unsuccessful attempts were made to grasp the central portion of the valve.Attempt was made to grasp the p3 scallop, but the clip did not fully close.The clip arms remained open with an approximate 50 degree angle.The grasp was released, clip was inverted and the clip was retracted into the left atrium.Troubleshooting maneuvers were performed and the clip was fully closed.The undeployed mitraclip system was removed from the anatomy and the procedure was aborted with zero clips implanted.Mr was untreated and remained grade 4.There was no additional information 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: 7235227
• MDR Text Key: 98837650
• Report Number: 2024168-2018-00756
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 70731U278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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
• Treatment: STEERABLE GUIDE CATHETER