MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM MINISLT-CVDNARR4.7MM; CRANIAL IMPLANTS

Model Number FT692T

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Foreign Body Reaction (1868); Swelling (2091)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing side we received a complaint about one ft692t: yasargil ti perm minislt-cvdnarr4.7mm.The implant is not available for investigation.Partially swollen brain was confirmed at the mri inspection few months after implanting ft692t.This patient has experienced 4 to 5 cases of implanting ft692t.These brain swollen was found at the contact points of the coil of the product and brain.Due to the administration of steroid, the patient's symptom has been improved little by little.Investigation: we heave no product at hand for the investigation.Batch history review: the device quality and manufacturing history records have been checked for the lot number (52497134 / 52509427 / 52518582) and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.It appears that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably patient related.Rationale: unfortunately due to a lack of data and without the product we can not determine the exact cause.According to the quality standard a material defect and production error can be excluded.There is the possibility for a patient related cause by an allergic reaction.In consultation with the senior project manager medical scientific affairs:" after consultation regarding the current case, an allergic reaction to titasnium cannot be ruled out.I have also researched the literature on this subject again.In general, foreign body reactions to titanium materials are extremely rare, so that other causes may have contributed to this complication.However, as it seems to be a case of abnormalities in the immediate vicinity of the clip, the foreign body reaction to titanium cannot be completely ruled out.There are also further publications on this subject available.However, the publication also focuses on nickel intolerance.However, since nickel is present in the titanium alloy used in the clip, even if only in small amounts, nickel incompatibility cannot be ruled out (even taking into account the fact that 5-6 clips have already been applied to the patient).However, this is only a vague assumption on my part.Basically, the authors recommend immunological examinations as part of the surgical planning." corrective action : according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.

Event Description

It was reported that there was an issue with yasargil ti perm minislt.It was reported that partially swollen brain was confirmed at the mri inspection after implanting ft692t.This patient has experienced 4 to 5 cases of implanting ft692t.This brain swelling seemed to be caused by the influence of coil of the product.It might be considered as foreign body reaction since these brain swellings were found at the inspection few months after the surgery and at the contact points of the coil of the product and brain.Treatment was required.Due to the administration of steroids, the patient's symptoms have improved little by little.An additional medical intervention was necessary.There is no revision planned to date.Additional information has been requested but is not yet available.The adverse event/malfunction is filed under (b)(4).

• Brand Name: YASARGIL TI PERM MINISLT-CVDNARR4.7MM
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9427613
• MDR Text Key: 170083919
• Report Number: 9610612-2019-00810
• Device Sequence Number: 1
• Product Code: HCH
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT692T
• Device Catalogue Number: FT692T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention