MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CASH 14 PLAT COIL 7MMX17CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SRC14071720
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.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., dba depuy synthes products, inc.((b)(4)).[conclusion]: 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 7 mm x 17 cm cashmere 14 stretch resistant coil (src14071720 / 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.(b)(4).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, and 3008114965-2019-01137.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 or Problem 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 7 mm x 17 cm cashmere 14 stretch resistant coil (src14071720 / lot #: unk) with respect to a potential intolerance / allergy.

• Brand Name: CASH 14 PLAT COIL 7MMX17CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8936569
• Report Number: 3008114965-2019-01136
• Device Sequence Number: 13560555
• Product Code: KRD
• UDI-Device Identifier: 00878528004028
• UDI-Public: 00878528004028
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K022420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SRC14071720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR