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); Bent (1059); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the unusual trajectory during advancement of the device handle.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr) and a restricted posterior leaflet.The clip delivery system (cds) was advanced to the mitral valve but it had an unusual anterior deflection in it's trajectory.During advancement of the handle, the slight bend was noted in the shaft.It was difficult to grasp the leaflets because of the unusual trajectory and was unable to reach the targeted location of the mr.The undeployed cds was removed from the anatomy and replaced with a new one.The procedure continued with the successful implantation of one mitraclip reducing mr to grade 1.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.

Manufacturer Narrative

(b)(4).Analysis was performed on the returned device and the reported dc [delivery catheter] shaft bend and difficulty positioning the device was confirmed.The reported failure to adhere or bond could not be replicated in a testing environment as it was related to patient/procedural conditions (operational circumstances).A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Review of the complaint history did not indicate a lot-specific quality issue.The investigation was unable to determine a conclusive cause for the dc shaft bend.The reported difficulty positioning the dc shaft was a result of the procedural circumstances/secondary effect of the bent dc shaft.The reported difficulty grasping the leaflets was a combination of the challenging patient anatomy (restricted posterior leaflet) and procedural conditions (secondary effect of difficulty positioning the dc shaft).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: 7614095
• MDR Text Key: 111901698
• Report Number: 2024168-2018-04597
• 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: 08/20/2018

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: 02/28/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80228U154
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• 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: 80 YR
• Patient Weight: 53