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

Catalog Number CDS0501

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Tissue Damage (2104)

Event Date 01/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The procedure was aborted after six hours; zero clips were implanted and mr grade was unchanged at grade 4.The patient is in stable condition and breathing independently.There was no additional information provided.The customer reported the clip delivery system was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The steerable guide catheter is filed under a separate medwatch report number.

Event Description

This is filed on the clip delivery system to report the torn leaflet and ruptured chord.It was reported that this was a mitraclip procedure to treat grade 4 mixed etiology mitral regurgitation (mr) in a patient with an exceptionally large left atrium (la), elongated fossa and a long, floppy eustachian valve.As the dilator and the steerable guide catheter (sgc) reached the la, the eustachian valve was noted to be wrapped/engaged with the sgc in the right atrium.In the la, two mobile pieces of tissue were noticed on the looped non-abbott guide wire.The sgc and dilator were suspected to have torn the eustachian valve.The dilator was removed and the guide wire was slowly retracted while strongly aspirating through the sgc.Two pieces of the eustachian valve were removed from the anatomy, one on the guide wire, the other was in the hemostatic valve of the sgc.As a precaution, a filter was placed during the procedure via the radial artery to prevent any possible embolization.The dilator and sgc were prepared and inspected; these performed fine so the procedure continued and the clip delivery system (cds) was advanced to the la.Visualizing the mitraclip was very challenging due to the large la.Grasping was unexpectedly a challenge.There was some prolapse on the anterior medial leaflet and what appeared to be an adequate posterior medial leaflet (pml) with some mitral annular calcification.The pml (very thin, restricted, calcified, frail leaflet) may have already had a small flail chord.After a few grasp attempts, the pml was suspected to have torn and a chord ruptured from the grasping attempt.This may have worsened the pre-existing flail.Other attempts to grasp elsewhere on the valve were made, but there was no mr reduction as there was no pml tissue to grasp at the site of maximum mr.The undeployed cds was removed from the anatomy.

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 this event.Review of the complaint history identified no other incidents reported for failure to adhere or bond from this lot.The reported patient effect of mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported failure to adhere or bond (difficulty grasping the leaflets) was related to the challenging patient anatomy (an exceptionally large left atrium, elongated fossa, a long, floppy eustachian valve, very thin, possibly fragile, restricted posterior leaflet and mitral annular calcification) and procedural circumstances, such as, difficulties visualizing the clip.The reported tissue damage appears to be related to procedural circumstances (maneuvers related to grasping attempts since the patient had a very challenging anatomy).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: 7246139
• MDR Text Key: 99181869
• Report Number: 2024168-2018-00873
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

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: 06/02/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70602U196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 04/27/2018
• Supplement Dates FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 78