MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP XTR DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0602-XTR

Device Problems Failure To Adhere Or Bond (1031); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

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 relevant information.The mitraclip xtr is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

This is filed to report the clip opened while locked and clip movement.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The first clip delivery system (cds 80209u136) was advanced to the mitral valve.The leaflets were grasped and the grippers were lowered.The final arm angle (faa) test was performed and the clip remained closed.The lock line was removed and the second faa test was performed.The clip remained closed.When the release pin was removed, the clip opened to approximately 60 degrees.The leaflets were re-grasped at a2/p2, reducing the mr to a moderate grade, with a mild medial mr jet and a moderate lateral mr jet.After clip deployment, it was noted that the medial mr increased to 3-4.And the lateral jet remained unchanged.A second clip was implanted later to the first clip to stabilize the first clip.There was no lateral mr remaining; however, the medial mr remained at 3-4.The pressure gradient was 5mmhg; therefore, no further clips were attempted.The patient was confirmed to be stable post procedure and both clips remain attached to both leaflets.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: all available information was investigated and the reported clip open while locked could not be tested due to the returned condition of the device (clip deployed and not returned).Additionally, the reported partial clip movement could not be replicated in a testing environment as it was related to patient/procedural conditions.A review of the lot history record revealed no manufacturing nonconformities to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.All available information was investigated and a definitive cause for the reported mechanical issue clip open while locked could not be determined in this incident.The reported failure to adhere or bond appears to be due to the reported mechanical issue as partial clip movement was suspected post deployment of the clip and the clip appeared unstable after second grasp.There is no indication of product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

(b)(4).Date corrected from 10/05/2018 to 11/05/2018.

• Brand Name: MITRACLIP XTR DELIVERY SYSTEM
• 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: 7626850
• MDR Text Key: 111942593
• Report Number: 2024168-2018-04796
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2019
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 80209U136
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2018
• 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): Required Intervention