MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM MINI-CLIPLGT-CVD5.2MM; CEREBRO VASCULAR CLIPS

Model Number FT726T

Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation results: the device was investigated visually, traces of usage and a quirk were discovered.In addition the device was sent to quality assurance of the production plant for further analysis.This report will be update as soon as further information is available.The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.According to the quality standard and dhr files a production error and a material defect can be excluded.Since these clips are subject to a 100% inspection of surface, geometry and closing force, a delivery condition with poor geometry is excluded as well.Investigations lead also to the assumption that the traces of usage were caused during surgery.The quirk could have caused by an improper handling.We assume that the clip wasn´t sat correctly and was therefore pulled out.According to the ifu the position of the clip should be double checked.The closing force test of the clip is still pending.Should the investigation reveal new evidence, leading to a different conclusion, this report will be adapted.According to the ifu the following points must be observed."damage to the clip due to incorrect handling, restriction of the functionality and the changing of the closing force! apply clip and ensure that occlusion of the aneurysm or vessel is archived and that the aneurysm clip sits correctly on the aneurysm neck during and after the implantation and sits tight with the blood vessel.Check the position of the clip and correct if necessary.To avoid damage to the aneurysm clips: always treat the aneurysm clips with appropriate care.Never open aneurysm clip with your fingers.Avoid manual and/or mechanical manipulation." (abstract of the ifu).A capa was not initiated.

Event Description

It was reported that there was an issue with a yasargil permanent clip.According to the complaint description the clip was pulled out one day postoperative.One day after surgery the surgeon found the clip absent at the location implanted but stayed at another position.Two new clips were used to replace the first one.Currently no patient problem is reported.A revision surgery was necessary.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Updated codes of h6.

• Brand Name: YASARGIL TI PERM MINI-CLIPLGT-CVD5.2MM
• Type of Device: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10478295
• MDR Text Key: 205273608
• Report Number: 9610612-2020-00465
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• PMA/PMN Number: K970050
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT726T
• Device Catalogue Number: FT726T
• Device Lot Number: 52246470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR