MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI TEMP CLIP 5.0MM FEN 9/15.7; CEREBRO VASCULAR CLIPS

Model Number FT150T

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a yasargil temporary clip.According to the customer during surgery a temporal clip was implanted.The neurosurgeon left a temporary clip implanted due to the risk of aneurysm rupture and requests safety information on these clips as definitive in this critical case.Additional information received: patient is stable at the moment.There was no patient harm.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: the devices are not available for investigation.The device history records have been checked for the available lot number and found to be according to the specification, valid at the time of production.There is no indication for a manufacturing error or a material failure.There are no similar complaints against the same lot number."the client reports that the surgeon left a temporary clip implanted due to risk of aneurysm rupture[.]".Regarding this statement and the notice in the ifu the root cause of the problem is most probably usage related.The implanted product is not intended to remain in the body permanently.In addition a section of the ifu states that the permanent prevention of vessels by means of temporary clips is contraindicated.As the patient is stabil at the moment any changes of the clips ( e.G.Position of the clip, migration) should be monitored.There is a increased risk of bleeding compared to the use of permanent clips.We recommend to replace the clips.

• Brand Name: YASARGIL TI TEMP CLIP 5.0MM FEN 9/15.7
• Type of Device: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10276017
• MDR Text Key: 232044478
• Report Number: 9610612-2020-00297
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• PMA/PMN Number: K983758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT150T
• Device Catalogue Number: FT150T
• Device Lot Number: 52442860
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1