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 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip remains in the patient.The clip delivery system was reportedly discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This report is filed as the lock line was unable to be removed.It was reported that this was a mitraclip procedure treating mixed, functional and degenerative, mitral regurgitation (mr) grade 4 with a short, restricted, and tethered posterior leaflet.The clip delivery system (cds) was advanced to the mitral valve.There was difficulty grasping the posterior leaflet.The patient's heart rate was increased with an external pacemaker and a successful grasp with good mr reduction was achieved.Clip deployment was initiated.Approximately 80% of the lock line was removed when resistance was noted and the lock line was unable to be removed any farther.Standard trouble shooting was performed, however, was unable to resolve the lock line issue.The clip was unable to unlock at this point so it was decided to continue with clip deployment.The mitraclip was deployed at the intended site and remained stable and well seated on the leaflets, reducing the mr to grade 1-2.The delivery system, containing the lock line, was removed from the anatomy without further issue.There was no adverse patient effect and there was no clinically significant delay.Once the delivery system was outside of the anatomy, the operator opened the device and examined the lock line.No knots were noted and no reason for this issue was observed.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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 identified no similar incidents reported from this lot.All available information was investigated and the reported failure to adhere or bond (difficulty leaflet grasping) appears to be related to patient morphology/pathology (short, restricted, and tethered posterior leaflet).The investigation was unable to determine a conclusive cause for reported mechanical jam of inability to remove the lock line.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
• MDR Report Key: 7582959
• MDR Text Key: 110859106
• Report Number: 2024168-2018-04320
• 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: 08/24/2018

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: 07/24/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70721U190
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 08/17/2018
• Supplement Dates FDA Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Age: 70 YR
• Patient Weight: 113