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); Detachment Of Device Component (1104); Product Quality Problem (1506); Difficult to Remove (1528); Incomplete Coaptation (2507)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report the clip movement, single leaflet device attachment (slda), detached clip, difficult to remove gripper line and tissue damage.It was reported that this was a mitraclip procedure to treat a degenerative mitral regurgitation (mr) with a grade of 4+.The first clip delivery system (cds) was advanced to the mitral valve.Grasping was performed with some difficulties, and during deployment, an attempt was made to floss the gripper line (gl), but it did not move.The gripper lines were twisted.Tension was released on the plus knobs 5 times and then were untangled and flossing was performed.Pulled one line and other line still moving with good grasp and the clip was deployed.During the attempt to remove the gripper line, there was clip movement and stopped pulling on the gripper line.However, the clip had detached from the anterior leaflet and remained attached to the posterior leaflet (slda).The gripper line was removed and the clip came off the posterior leaflet and was still attached to the gripper line.Tension was maintained and the gripper line was secured.The entire system was pulled out to the groin and a snare device was used to explant the clip.At this point, the procedure was aborted.No additional information was provided.

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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and the reported difficulty grasping appears to be related to the challenging patient morphology/pathology (prolapse flail (p2)).The reported single leaflet device attachment (slda) appears to be related to a combination of challenging patient anatomy/pathology and procedural conditions (tension on the system from trying to floss the gripper line).The reported partial clip movement and complete clip detachment (ccd) appear to be a result of the procedural conditions (maneuvers related to removing the gripper line).The reported difficulty to remove the gripper line was a secondary effect of the physical property issue with gripper line (twisted gripper line).However, a definitive cause for the gripper line issue could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing 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: 7515493
• MDR Text Key: 108300800
• Report Number: 2024168-2018-03596
• 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: 09/05/2018

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: 11/02/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71102U106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 85 YR
• Patient Weight: 88