MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number PC410041230

Device Problems Positioning Failure (1158); Premature Activation (1484); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

Udi: lot number unknown; (b)(4).Mfg name codman & shurtleff, inc.Dba depuy synthes products, inc.Three attempts to obtain additional information have been unsuccessful.It was reported that the device would be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during the procedure, presidio10 coil (catalog pc410041230, lot unk) could not be detached.The surgeon tried to withdraw the coil.The coil detached during withdrawal.A ring of coil protruded in the parent artery.The surgeon deployed enterprise stent to complete the procedure.There was no report on the patient injury.It was reported that the device would be returned for analysis.

Manufacturer Narrative

It was reported that the device would be returned for analysis; however, the device was not returned and no additional information could be obtained.During the procedure, the presidio 10 coil (pc410041230/ lot unk) could not be detached.The surgeon tried to withdraw the coil.The coil detached during withdrawal.A ring of coil protruded in the parent artery.The surgeon deployed an enterprise stent to complete the procedure.There was no report of the patient injury.It was reported that the device would be returned for analysis; however, the devices was not returned and no additional information could be obtained.The device was not returned for analysis.The lot number of the affected product was not provided, and without the lot number, manufacturing documentation could not be reviewed.The coil detachment, premature detachment and protrusion into the parent vessel could not be confirmed without product return for analysis.Based on the minimal information provided, the root cause of the events could not be determined.Procedural factors may have contributed to the events.There ar no current safety signals identified related to the reported events based on review of complaint histories for the device.Since there was no evidence to suggest the events was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: PRESIDIO 10 - CERECYTE MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• Manufacturer Contact: joaquin kurz ; 47709 freemont blvd; freemont, CA 94538 ; 9497899383
• MDR Report Key: 6989840
• MDR Text Key: 90644496
• Report Number: 3013875781-2017-00019
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PC410041230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention