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

Device Problem Incomplete Coaptation (2507)

Patient Problem No Information (3190)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event - estimated.Date of implant - estimated.The clips remain in the patients.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Article: "outcome after percutaneous edge-to-edge mitral repair for functional and degenerative mitral regurgitation: a systematic review and meta-analysis.".

Event Description

This is filed for single leaflet device attachment (slda).It was reported through a research article identifying the mitraclip device that may be related to single leaflet device attachments.Specific patient information is documented as unknown.Details are listed in the article, titled "outcome after percutaneous edge-to-edge mitral repair for functional and degenerative mitral regurgitation: a systematic review and meta-analysis.".

Manufacturer Narrative

Internal file number (b)(4).The unique device identifier (udi) is unknown because the part and lot numbers were not provided.The device was not returned for analysis.The lot history record (lhr) could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.All available information was investigated and a definitive cause for the single leaflet device attachment (slda) 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
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8313589
• MDR Text Key: 135726333
• Report Number: 2024168-2019-00917
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1