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); Entrapment of Device (1212); Difficult To Position (1467); Difficult to Open or Close (2921); Mechanical Jam (2983); Torn Material (3024)

Patient Problem Tissue Damage (2104)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

The patient and device codes were coded by the manufacturer.(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 is filed to report the clip caught in the anatomy requiring surgery.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 and challenging leaflet anatomy.The clip delivery system (cds) was advanced to the mitral valve.During the procedure, while rotating and translating the cds handle, the clip would move toward the medial commissure.This movement appeared to be due to the pulsation of the heart.Grasping was difficult due to the leaflet anatomy and the clip became stuck in the commissure.It was noted that the gripper lever was retracted further than normal, approximately 5-8mm from the blue marker.Troubleshooting was performed, but the clip could not be freed.The clip arms were not opening or closing, no clip rotation could be done, and there was no movement in any direction.The decision was made to convert to open heart surgery.During the surgery, the clip was found to be twisted on the leaflet and the posterior leaflet was damaged between p2 and p3.With visual guidance, the physician was able to detach and retrieve the clip into the steerable guide catheter (sgc) and out of the patient.The covering fabric of the clip was torn and grippers were not symmetric.The leaflet damage was treated during surgery.There was a clinically significant delay as the patient was sent to surgery.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: lot number changed from 780216u217 to 80216u217.Evaluation summary: all available information was investigated and the reported difficult delivery catheter (dc) shaft positioning, torn material, gripper actuation issue (based on photo received from the account) was confirmed.The mechanical jam of inability to close the clip was not confirmed.The reported entrapment of device or device component, failure to adhere or bond (leaflet grasping) and failure to adhere or bond (leaflet capture) could not be replicated in a testing environment as they were 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 identified no similar incidents reported from this lot.The investigation determined the reported difficulty positioning the device and failure to adhere or bond appears to be related to patient morphology/pathology (pulsation of the heart and anterior prolapse and large left atrium).The reported gripper actuation issue appears to be related to user technique of retracting the gripper lever as no issue was observed with the gripper during returned device analysis.The entrapment of device or device component was due to the difficulty positioning the device; therefore, attributed to procedural conditions.The analysis was unable to determine a definitive cause for the torn material (clip cover) and mechanical jam of inability to close the clip.The reported tissue damage was due to the entrapment of the clip (procedural conditions).The reported patient effects of tissue damage, as listed in the mitraclip system instructions for use is known possible complications associated with mitraclip procedures.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: 7499841
• MDR Text Key: 107770743
• Report Number: 2024168-2018-03413
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

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: 02/17/2019
• Device Catalogue Number: CDS0502
• Device Lot Number: 80216U217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 07/20/2018
• Supplement Dates FDA Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 81 YR
• Patient Weight: 70