MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number UNK SGC03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 09/16/2014

Event Type  Death  

Manufacturer Narrative

The device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Literature article title ¿persistence of iatrogenic atrial septal defect after interventional mitral valve repair with the mitraclip system: a note of caution.¿.

Event Description

This is being filed to report the patient death.It was reported through a research article identifying mitraclip that may be related to patient death and atrial septal defects.Specific patient information is documented as unknown.Details are listed in the article: persistence of iatrogenic atrial septal defect after interventional mitral valve repair with the mitraclip system: a note of caution.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record could not be performed as lot and part numbers were not provided.Based on the available information, a cause for the reported death could not be determined.The reported patient effect of death is listed in the mitraclip system instructions for use and is a known possible complication of mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11156434
• MDR Text Key: 226318554
• Report Number: 2024168-2021-00349
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR