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 Problems Dyspnea (1816); Mitral Regurgitation (1964)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the clip movement on the leaflet.It was reported that initial mitraclip procedure was performed on (b)(6) 2017, to treat degenerative mitral regurgitation (mr) with a grade of 4+.1 clip was implanted successfully reducing mr grade to 1+-2.On (b)(6) 2018, the patient presented with shortness of breath.No treatment was performed.On (b)(6) 2018, the patient presented for a follow-up mitraclip procedure and it was noted that the implanted clip moved on the posterior leaflet, but was still slightly attached to the leaflet.The movement was noted to be due to the patients anatomy.Mr grade increased to 4.One clip was implanted reducing mr grade to 2.The patient was reported as doing well post procedure.No additional information was provided.

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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effects of dyspnea and recurrent mitral regurgitation (mr), as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.All available information was investigated and the reported partial clip movement appears to be related to the pre-existing patient anatomy.The reported recurrent mr was due to the partial clip movement and the reported dyspnea was likely the secondary effect of the recurrent mr.Based on the information reviewed, 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: 7574760
• MDR Text Key: 110269321
• Report Number: 2024168-2018-04201
• 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: 08/21/2018

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: 08/29/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70829U138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 08/21/2018
• Supplement Dates FDA Received: 08/21/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 90 YR