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

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	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
Correction: type of reportable event changed from malfunction to serious injury.Investigation - evaluation a review of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events which could contribute to this failure mode.A complaint search revealed this complaint and one other complaint, which is connected to this complaint, to be the only reported complaints associated to the complaint lot number.The instructions for use provides the warning: "coils should not be left too close to the inlets of arteries and should be intermeshed with previously placed coils if possible" and instructs to perform a final angiogram to confirm coil position within target vessel.Based on the provided information, no product returned, and the investigation, a probable root cause was related to the user technique in deploying the coil during the original procedure.Per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• 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: 6683452
• Report Number: 1820334-2017-01610
• Device Sequence Number: 13487099
• Product Code: KRD
• UDI-Device Identifier: 00827002269958
• UDI-Public: (01)00827002269958(17)160501(10)2722727
• 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): 09/21/2017

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-35-14-8-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: 09/21/2017
• 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