MAUDE Adverse Event Report: COOK INC NESTER PLATINUM EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Reaction (2414); No Code Available (3191)
Date of Event	04/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
Per fda mw5069779: ¿removal of cook medical nester coils after adverse allergic reaction and migration to the renal vein.Surgical opinion upon removal was that these coils were released too close to the renal vein.Pt was implanted with coils to treat ¿pain¿ reported to his physician.The physician advised that he believed the pt.To have varicocele and required embolization as a treatment.After implantation, the pt experienced elevated eosinophils, increased discomfort in the treated area.Rapid decrease of total testosterone (below normal range of 300), poor liver function.Pt had no previous medical history of these issues prior to implantation, additionally, the pt was unable to perform basic tasks that he previously had no issues performing (such as driving a manual transmission vehicle).The pt had the coils removed on (b)(6) 2017 by dr.Who was able to successfully remove the coils.¿ this is one of six medwatch reports being submitted as the customer reported two separate events involving three different product lot numbers.Reference mdr numbers: 1820334-2017-01607, 1820334-2017-01608, 1820334-2017-01609, 1820334-2017-01610, 1820334-2017-01611, 1820334-2017-01612 the same patient is involved in all reports.
Additional Manufacturer Narrative
Investigation evaluation: a review of documentation, manufacturing instructions, specifications and quality control data was conducted during the investigation.The device history record was reviewed and no non-conformances were noted.Additionally, there have been no additional complaints on this lot.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.Review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Biocompatibility testing was performed.The results of the testing did not show any toxic reactions.All biocompatibility testing passed and the materials comprising embolization devices have been proven to be clinically safe.The raw material (platinum) in the embolization coil is specified to certain purity levels and numerous controls are in place to make certain the material is properly washed and is free of debris throughout the manufacturing process.Validated processes ensure the device is manufactured in a clean environment and that the final device is sterile.Biocompatibility testing was completed on the materials used in the embolization coil according to the governing standards.It is possible that the patient had an allergic reaction to the materials in the embolization coils or that the presenting symptoms were due to the migration of the coils irritating the surrounding tissue (causing inflammation) and not the coils themselves.The devices were not returned.No photos or imaging was provided.Without contact with the reporting physician we are unable to obtain additional information at this time.For these reasons, a definitive root cause could not be determined.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: NESTER PLATINUM EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6683446
• Report Number: 1820334-2017-01611
• Device Sequence Number: 138580
• Product Code: KRD
• UDI-Device Identifier: 00827002269941
• UDI-Public: (01)00827002269941(17)160501(10)2724141
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2017

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 Model Number: N/A
• Device Catalogue Number: MWCE-35-14-6-NESTER
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 07/01/2017
• Supplement Report FDA Received Date: 09/25/2017
• 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: Required Intervention