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

Catalog Number CDS0201

Device Problems Failure To Adhere Or Bond (1031); Incomplete Coaptation (2507)

Patient Problems Mitral Regurgitation (1964); Heart Failure (2206)

Event Date 12/19/2017

Event Type  Injury  

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.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is being filed to report a partial single leaflet device attachment (slda).It was reported that the initial mitraclip procedure was performed on (b)(6) 2017, to treat degenerative mitral regurgitation (mr) with a grade of 4.Two clips (60907u153, 60907u151) were implanted, reducing the mr to 1.On (b)(6) 2017, a follow up echocardiogram was performed as the patient was experiencing heart failure symptoms.It was found that the second implanted clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).On (b)(6) 2018, a second mitraclip procedure was performed for treatment.The mr was 4.It was found that the slda clip was potentially also detached from the anterior leaflet, and only attached to the anterior chordae.The clip delivery system (lot # 71011u117) was advanced for treatment.When attempting to grasp the leaflets, the chordae was grasped, and a chordal rupture occurred.It was observed that the slda clip starting flailing in the left atrium (la) and was more mobile.The decision was made to deploy the clip, remove the cds, leave the gripper line in place and send the patient to surgery.The patient was successfully treated with mitral valve replacement surgery.During surgery, the clips were investigated and the second slda was attached to the tip of the anterior leaflet but mostly the chord and no posterior.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record for both implanted clips identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue for these lots.All available information was investigated and the reported slda and failure to bond/adhere in this incident is related to the challenging patient morphology/anatomy (barlows leaflets, thick prolapsing leaflets).The reported worsening mr was likely a result of patient/procedural conditions due to the slda.The reported worsening heart failure was a cascading effect of recurrent mr.The reported patient effects of worsening mitral regurgitation(mr), worsening heart failure, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP 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: 7187947
• MDR Text Key: 97332402
• Report Number: 2024168-2018-00344
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/24/2018

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: 09/08/2017
• Device Catalogue Number: CDS0201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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): Hospitalization; Required Intervention; Disability