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); Break (1069); Entrapment of Device (1212); Difficult to Open or Close (2921)

Patient Problems Mitral Valve Stenosis (1965); Tissue Damage (2104); Foreign Body In Patient (2687)

Event Date 05/09/2018

Event Type  Injury  

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 additional relevant information.

Event Description

This event is filed for gripper line break, entrapment of the clip, tissue damage, mitral stenosis and implantation of the clip at an unintended location.It was reported that the patient, with degenerative mitral regurgitation (mr), underwent a mitraclip procedure.The clip delivery system (cds) was advanced and attempts were made to grasp the leaflet.During the 8th grasp attempt, the gripper line broke and the gripper was noted to be caught on the leaflet.The gripper could not be raised due to the gripper line break and the clip was deployed where it became caught, which was on both leaflets, but not at the location the physician wanted to deploy the clip.It was noted that the mean pressure gradient increased to 8 mmhg and a posterior flail was present.The flail was thought to have occurred during attempts to move the clip further into the ventricle when the gripper was stuck on the leaflet.The mr was reduced from grade 4 to grade 3-4; however, due to the increased mean pressure gradient, no additional clips were implanted.The broken gripper line was able to be removed through the gripper lever.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: only the broken gripper line was returned.The reported gripper line break was confirmed as it was returned broken.The reported failure to adhere or bond and entrapment of the device component could not be replicated in a testing environment as they were related to patient/procedural conditions (operational circumstances).As the device was not returned, the reported gripper actuation issue could not be replicated in a testing environment.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 indicate a lot-specific quality issue.The reported patient effects of mitral stenosis, tissue damage, foreign body in patient as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.All available information was investigated and the reported failure to adhere or bond to the leaflets (difficulty grasping) appears to be related to patient morphology/pathology (posterior prolapse).The gripper line break and subsequent gripper actuation issue and entrapment of the device component was due to the maneuvers performed while attempting to grasp the leaflets; therefore, contributed to procedural conditions.The patient effect mitral stenosis was due to the flail and the flail was due to attempts to move the clip.The foreign body in patient was due the clip being deployed where it was caught.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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: 7555091
• MDR Text Key: 109615772
• Report Number: 2024168-2018-04001
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

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: 03/01/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80228U253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 08/03/2018
• Supplement Dates FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• 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
• Patient Age: 74 YR
• Patient Weight: 62