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

Catalog Number CDS0502

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Mitral Regurgitation (1964); Tissue Damage (2104)

Event Date 01/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This report is filed on the second clip delivery system for leaflet laceration after difficult leaflet grasping.It was reported that this was a mitraclip procedure treating functional mitral regurgitation (mr) grade 4.The patient presented with fibrotic leaflets and the medial and lateral portions of the mitral valve were thin.One mitraclip was implanted without reported issue and with satisfactory leaflet insertion.Mr was reduced to grade 2-3.A second clip delivery system (cds 70731u357) grasped the leaflets, however, there was inadequate leaflet insertion.The leaflets were grasped a second time; however, there was still inadequate leaflet insertion.Reportedly, it was difficult grasping the posterior leaflet.After the third grasping attempt and per echocardiogram, a new severe jet was noted through and lateral of the second mitraclip.This mitraclip was inverted and retracted into the left atrium.A laceration was observed on the posterior medial leaflet at the anterior 1 and posterior 1 segment.Mr returned to grade 4.This mitraclip was not implanted and the device was removed from the anatomy.There was no treatment provided and mr remains grade 4.The patient is in stable condition.The first implanted mitraclip remains stable and well seated on the leaflets.There was no additional information 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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported patient effects of worsening mitral regurgitation (mr) and tissue damage, as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.All available information was investigated and the reported failure to bond (leaflet capture-clip not implanted) appears to be related to the challenging patient morphology/pathology (fibrotic leaflets, thin medial and the lateral part of the mitral valve resulted in inability to capture leaflets and finally not implanting the clip and removing device from anatomy).The reported mitral valve injury (tissue damage) appears to be related to the challenging patient morphology/pathology (fibrotic leaflets, thin medial and lateral part of mitral valve) and procedural circumstances (maneuvers related to capturing the leaflets).The reported unchanged mr appears to be a result of procedural conditions as the device was removed from the anatomy, mr went back to initial grade 4.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: 7255492
• MDR Text Key: 99548704
• Report Number: 2024168-2018-00943
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

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: 08/01/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 70731U357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 05/11/2018
• Supplement Dates FDA Received: 05/17/2018
• 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