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

Catalog Number UNK MITRA CLIP DS

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report that post clip implantation clip movement was noted.It was reported that the initial mitraclip procedure was performed on an unspecified date to treat degenerative mitral regurgitation (dmr) with an unspecified mr grade.One clip was implanted reducing the mr to an unspecified mr grade.On an unspecified date, the patient returned and an echocardiogram was performed, which found that there was a partial leaflet detachment at the posterior leaflet.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified could not be performed, as the lot number for the device was unknown and could not be provided.All available information was investigated and a definitive cause for the failure to adhere or bond (partial clip movement) in this incident could not be determined.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
• 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: 7232592
• MDR Text Key: 98732478
• Report Number: 2024168-2018-00731
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/24/2018

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 Catalogue Number: UNK MITRA CLIP DS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 04/20/2018
• Supplement Dates FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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