MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL G2 TDL COMPLEX FILL COIL 4X12; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number 641CF0412

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

Patient Problem Headache (1880)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Date of event: the event occurred in 2017, however, the month and date of the event were not reported.The device lot number is not available/not reported.The expiration date of the device is not known.Implantation date: the procedure was in 2017, however, the month and the date of the procedure was not reported.Information related to the initial reporter such as facility name, address, phone and email address are not available.The device manufacture date is not known as the device lot number is not available/not reported.Physical manufacturer name: codman and shurtleff inc., (b)(4).The patient who underwent a coil embolization procedure that targeted a basilar aneurysm two years ago in 2017, reached out to a sales rep to report that she is suffering from a headache that has turned into a chronic, permanent headache.The patient would like to know the material composition of the 4mm x 12cm orbit galaxy g2 complex fill coil (641cf0412/lot#: unk) with respect to a potential intolerance/allergy.Additional information regarding patient presentation as related to the procedure from two years ago and to the current symptom was requested; however, the information is not available.Based on complaint information, the device remains implanted and is thus not available for evaluation.The device lot number was not available.The device history record (dhr) review could not be performed without the lot number.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.In addition, there was no report of any device malfunction.As a result, we are closing this investigation.Hyper-immune response and headache are known potential complications associated with the use of embolic coils in treatment of intracranial aneurysms.The materials of the coil implant consist mainly of 92% platinum/8% tungsten for the coil itself and pga for the internal stretch resistant fiber bundle.All alloys will also contain trace levels of other metal impurities, typically measured in parts per million.Without lot numbers, it is not possible to review the certificate of analysis that would specify such impurity levels.Placing foreign materials (i.E.Coils) in the patient can result in allergy; however, based on the limited information available for review, it is not possible to determine if the reported headache was triggered by a coil allergy/hyper-immune response.It is currently unknown if allergy testing and/or follow-up angiography has been performed and if the headache required treatment and/or hospitalization.The root cause of the event cannot be conclusively determined at this time.Since the headache was reported to be chronic and permanent and the relationship of the devices to the reported event cannot be excluded, the event meets mdr reporting criteria for all implanted codman cnv/cerenovus coils.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is one of three products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2019-01135, 3008114965-2019-01136, and 3008114965-2019-01137.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The patient who underwent a coil embolization procedure that targeted a basilar aneurysm two years ago in 2017, reached out to a sales rep to report that she is suffering from a headache that has turned into a chronic, permanent headache.The patient would like to know the material composition of the 4mm x 12cm orbit galaxy g2 complex fill coil (641cf0412/lot#: unk) with respect to a potential intolerance/allergy.

• Brand Name: G2 TDL COMPLEX FILL COIL 4X12
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): SEE H.10; 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8936552
• MDR Text Key: 160532919
• Report Number: 3008114965-2019-01137
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10878528009556
• UDI-Public: 10878528009556
• Combination Product (y/n): N
• PMA/PMN Number: K120686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 641CF0412
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR