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

Catalog Number CDS0501

Device Problems Failure To Adhere Or Bond (1031); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.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 inability to remove the gripper line.It was reported that on (b)(6) 2018, the patient, with degenerative mitral regurgitation (mr), underwent a mitraclip procedure treating mr of grade 4+.The patient anatomy included a posterior flail.The clip delivery system (cds) was advanced and multiple attempts were made to grasp the leaflet; however, due to the posterior flail, the clip was unable to grasp the leaflets.After multiple attempts, the clip was able to grasp the leaflet, but the mr was not reduced.The physician decided to deploy the clip and then evaluate the patient for surgical mitral valve replacement surgery.Gripper line removability was tested; however, the gripper line could not be flossed and no movement of the gripper line was noted.Both ends of the gripper line were tested, but neither could be moved.The gripper lines were checked to make sure they were separated and there were no knots noted.The gripper lines were re-wrapped onto the gripper lever.The grippers were raised without issue.The clip was unlocked, inverted, and brought back up into the left atrium.The cds was removed from the anatomy without issue.The mr remained unchanged at grade 4+ and there was no adverse patient effect.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned.All available information was investigated and the reported inability to remove the gripper line was confirmed.The reported failure to adhere or bond could not be replicated in a testing environment as it was related to patient/procedural conditions (operational circumstances).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.All available information was investigated and the reported failure to adhere bond to the leaflets appears to be related to patient morphology/pathology due to the posterior flail.A definitive cause for the reported inability to remove the gripper line in this incident could not be determined.Subsequently, the inability to remove the gripper line was likely due to a contribution of forces from usage of the device (procedural interaction) in conjunction with the herniation in the lumen coil.There is no indication of 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
• MDR Report Key: 7562420
• MDR Text Key: 110047857
• Report Number: 2024168-2018-04074
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2018

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: 01/09/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80108U238
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• Supplement Dates FDA Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: STEERABLE GUIDE CATHETER
• Patient Age: 74 YR
• Patient Weight: 76