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); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The clip delivery system was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the inability to remove the gripper line.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced to the mitral valve.Grasping was difficult and performed for approximately 2 hours.The leaflets were successfully grasped and an attempt was made to establish gripper line removability (eglr); however, the gripper line would not move in any direction.No excessive tension or misalignment was observed on the system.Troubleshooting was performed, but the gripper line did not move.As grasping had taken 2 hours, the decision was made to deploy the clip and leave the gripper line in the patient.During the deployment sequence, additional attempts were made to remove the gripper line, but were unsuccessful.The clip was deployed, reducing the mr to 2.The mitraclip system was removed and the gripper line was cut at the groin.The patient was stable post procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned and investigated.The reported inability to remove the gripper line was confirmed.Additionally, the reported failure to adhere or bond (leaflet grasping) could not be replicated in the testing environment as it was likely a result of procedural condition and/or patient morphology/pathology conditions.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have resulted in this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effect of foreign body in patient as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.A definitive cause for the reported inability to remove the gripper line and failure to adhere or bond could not be determined.The observed difficult to remove the gripper line appears to be a cascading effect of reported mechanical jam.There is no indication of product quality issue with respect to manufacture, design or labeling.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, 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: 7310601
• MDR Text Key: 101412926
• Report Number: 2024168-2018-01522
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 03/26/2018

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: 02/15/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71113U279
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 03/21/2018
• Supplement Dates FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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
• Patient Outcome(s): Required Intervention