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); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The mitraclip remains in the patient and the clip delivery system was reportedly discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This report is filed since the mitraclip opened unexpectedly to 60 degrees.It was reported that this was a mitraclip procedure treating degenerative mitral regurgitation (mr) grade 4, with a posterior leaflet flail and shredded leaflets.The clip delivery system was advanced to the mitral valve leaflets and grasping was performed 8-10 times.Reportedly, there was difficulty grasping with the clip arms due to anatomy.The mitraclip was placed on the mitral valve leaflets per instructions for use and during final arm angle, the clip opened 60 degrees.The arm positioner was closed all the way to a hard stop and the clip did not open again.The clip was deployed and remained stable and well seated on the leaflets.The mr was reduced to grade 1-2.There were no adverse patient effects and there was no clinically significant delay.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 revealed 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.All available information was investigated and the reported failure to adhere or bond (difficulty in leaflet grasping) appears to be related to the patient morphology/pathology (posterior leaflet flail and shredded leaflets).All available information was investigated and a definitive cause for the difficulty to establish final arm angle (faa) in this incident could not be determined.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: 7419612
• MDR Text Key: 105384280
• Report Number: 2024168-2018-02618
• 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: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80108U258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 06/14/2018
• Supplement Dates FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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 Age: 76 YR
• Patient Weight: 95