MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM STD-CLIP STR 7MM; CRANIAL IMPLANTS

Model Number FT740T

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 10/19/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a yasargil ti perm std-clip str 7mm (part # ft740t) was used during a procedure performed on (b)(6) 2021.According to the complainant, the position of the clip deviated a few millimeters (mm) distally from the aneurysm neck and the position of the initial clip closure.The patient underwent a revision procedure on (b)(6) 2021.During the revision surgery, the surgeon used a blade that was 2 mm longer in order to close the same position again.Additionally, the surgeon used a booster clip as a precaution.The complaint device was returned to the manufacturer for evaluation.A revision surgery was necessary.No calcification or hardening of the aneurysm neck was observed.The adverse event is filed under aag reference (b)(4).

Event Description

Clarification: a week postoperatively, the position of the clip had been deviated a few mm distally from the aneurysm neck and the position of the initial clip closure.Approximately 2 weeks after the product was used (closed) by clipping, the clip slipped out and re-rupture occurred at the same site.Currently, the revision procedure has been completed.

Manufacturer Narrative

B5 - updated description: investigation: visual investigation was performed.We did not find any gap between the jaws but we detected traces of wear.Furthermore, the product was sent to the production department.Based on the analysis of the subject matter expert, this is the current condition: - the clip no longer covers and closes completely - the closing force is 100g, and outside the tolerance - strong pressure marks can be seen on the spring.Cause - due to the strong pressure marks, as the clip no longer covers and also no longer closes completely, we assume that the wrong application pliers were probably used during the operation; as a result, the clip was "crushed" during application, and this also explains the insufficient closing force.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) 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.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based on the investigation results, a capa is not required.

• Brand Name: YASARGIL TI PERM STD-CLIP STR 7MM
• Type of Device: CRANIAL IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12821381
• MDR Text Key: 280944296
• Report Number: 9610612-2021-00723
• Device Sequence Number: 1
• Product Code: HCH
• UDI-Device Identifier: 04038653171460
• UDI-Public: 4038653171460
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K970050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT740T
• Device Catalogue Number: FT740T
• Device Lot Number: 52551212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2019
• 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): Required Intervention