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 06/08/2018

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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

This report is filed since the gripper line was unable to be removed.It was reported that this was a mitraclip procedure treating functional mitral regurgitation (mr) grade 4 with significant gap and tethered posterior leaflet.Reportedly, imaging was difficult due to patient anatomy, a tilted heart, and the probe was heating up and produced degraded images.The first mitraclip (cds0501 80424u219) was difficult to grasp the leaflets due to anatomy.Once positioned, and while establishing gripper line removability, the gripper line would not floss.Immediate resistance was noted when removing the gripper line.Standard troubleshooting was performed without success and the cds with undeployed clip was removed from the anatomy.After 2 hours of trying, a second mitraclip was unable to grasp the leaflets due to anatomy without inducing a high mitral valve pressure gradient.The undeployed clip delivery system was removed and mitral valve pressure gradient returned to baseline.The procedure was aborted with no clips implanted and mr remained grade 4.There was no adverse patient effect and no clinically significant delay.The patient will get a ventricular assist device.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).All available information was investigated and the reported inability to remove the gripper line was confirmed.The reported failure to adhere or bond and poor image resolution 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 issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported failure to adhere/bond to the leaflets, inability removing the gripper line, and poor image resolution appears to be related to a combination of patient morphology/pathology and procedural conditions.In addition, herniation on the lumens combined with aggregations of forces due to patient anatomy and curves on the system can also contribute to the reported inability removing the gripper line.However, a definitive cause for the observed herniation cannot be determined.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
• 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: 7635205
• MDR Text Key: 112315414
• Report Number: 2024168-2018-04973
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80424U219
• 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: 09/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• 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