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); Improper or Incorrect Procedure or Method (2017); Incomplete Coaptation (2507)

Patient Problems Embolism (1829); Foreign Body In Patient (2687)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: steerable guide catheter, 1 implanted mitraclip, pacemaker.(b)(4).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 report is filed since the deployed mitraclip detached and embolized into the pulmonary artery.It was reported that this was a mitraclip procedure treating tricuspid regurgitation (tr) grade 4.The patient presented with a pacing lead and thin tricuspid leaflets.The first clip delivery system (cds) was advanced and there was difficulty grasping the leaflets due to a pre-existing pacing lead.The mitraclip was implanted on the tricuspid leaflets, reducing the tr to grade 2.In attempt to further reduce tr, cds 71027u165 was deployed on the tricuspid leaflets.Once deployed, the mitraclip detached from the posterior leaflet and was hanging on the tip of the anterior septal leaflet.This clip then completely detached and embolized into the pulmonary artery.It was decided to leave the embolized clip in the pulmonary artery.The procedure was ended and the final tr was grade 2.Reportedly, the patient is doing well and the hepatic flow which was reversed prior to the mitraclip procedure had normalized post procedure.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 the reported event.Review of the complaint-handling database was performed for the reported lot and did not indicate a lot-specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.All available information was investigated and the reported difficulty grasping, single leaflet device attachment and complete clip detachment appears to be related to the challenging patient morphology/pathology.The reported embolism and foreign body in patient were due to the complete clip detachment.The reported use error (improper or incorrect procedure or method) was associated with the use of the mitraclip device on the tricuspid valve, which is considered an off-label use of the device.It should be noted that the mitraclip instructions for use (ifu) under the indication for use section on page 3 states: the mitraclip nt clip delivery system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (mr >/ 3+) due to primary abnormality of the mitral apparatus [degenerative mr] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.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: 7535378
• MDR Text Key: 108976212
• Report Number: 2024168-2018-03827
• 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: 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: 10/27/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71027U165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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
• Patient Age: 77 YR
• Patient Weight: 87