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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Mitral Valve Stenosis (1965); Tissue Damage (2104)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: other mitraclip (part #70621u132).Steerable guide catheter (part #80124u127).The mitraclip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This report is being filed since post mitraclip deployment, a small chordal rupture was observed and the mean mitral valve gradient was 6 mmhg.It was reported that this was a mitraclip procedure treating functional mitral regurgitation (mr) grade 4 with slightly thick leaflets.One mitraclip was implanted on the medial anterior leaflet 2 (a2) and posterior leaflet 2 (p2) leaflets without issue.Residual mr was present so a second mitraclip (cds 70807u125) was positioned on the lateral a2/p2 area.Although grasping was performed without issue, the first grasp attempt was not satisfactory.The second grasp was deemed successful, reducing the mr to grade 1-2.Leaflet insertion assessment was satisfactory and this clip was deployed.Post deployment and while removing the delivery system, a residual higher mr was noted and a small chordal rupture occurred just lateral to the second implanted clip.The mean gradient was 6 mmhg and it was decided not to implant a third clip as treatment.The mr had been reduced to grade 2 and the procedure ended.No treatment was reported.There was no adverse patient sequela and there was no clinically significant delay.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the previously filled medwatch report, additional information was obtained: the leaflets could be grasped easily with cds 70807u125, however, the residual mitral regurgitation was not satisfactory on the first grasp.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of tissue damage and mitral stenosis, as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported tissue damage and mitral stenosis in this incident appears to be related to patient morphology/pathology and/or user technique/procedural conditions; and unrelated to the device since there was no reported device issue/malfunction during the procedure.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: 7596739
• MDR Text Key: 110912897
• Report Number: 2024168-2018-04440
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 08/22/2018

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: 08/07/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 70807U125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 06/18/2018; 08/14/2018
• Supplement Dates FDA Received: 07/09/2018; 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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
• Patient Outcome(s): Other