MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME COIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR100829
Medical Device Problem Codes	Fracture (1260); Stretched (1601); Physical Resistance (2578)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is initial mdr report being submitted with associated mfr# 2954740-2017-00086 and 3008264254-2017-00045.Additional procode: krd, (b)(4), manufacturing date currently not available.The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that resistance was experienced when a micrusframe coil was used and the coil separated in patient.The procedure was stent-assisted coil embolization for treatment of an 9 mm internal carotid artery aneurysm.The patient had very tortuous vessels.A 3 mm enterprise stent (lot unknown) was placed across the neck of the aneurysm.The physician then tried to advance a prowler lpes 150 cm, however due to tortuosity the catheter would not cross the stent into the aneurysm.It was then decided to use a prowler14 170 cm catheter which successfully entered the aneurysm.Then a micrusframe 8 x 29 cm coil was used which was deploying well until it was hubbed.The coil was partially deployed in the aneurysm when the coil could not be advanced any further, 3 cm was left inside the catheter.When an attempt was made to remove the coil, the coil got stuck.As the physician pulled the coil, back half of the coil became lodged behind the stent and the other half stretched inside the ica down to the femoral and broke into 2 separate pieces.It was reported that the first two loops got lodged behind the stent.It was reported that the surgery was delayed by 30 minutes due to the attempts to remove the broken coil.The separated coil pieces were not retrieved from the patient.The procedure was ended; the patient will be brought back to access and coil at a later date.The complaint devices are not available for return.
Additional Manufacturer Narrative
This is follow-up report being submitted with associated mfr# 2954740-2017-00086 and 3008264254-2017-00045.The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This is final mdr report being submitted with associated mfr# 2954740-2017-00086 and 3008264254-2017-00045.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Impeded, separated and unraveled/stretched are all known potential product failures associated with the use of the codman microcoils devices.Surgical delays associated with product malfunctions are a well-known potential adverse event associated with all interventional procedures.The codman microcoil ifu includes warnings and instructions for use to trouble shoot these various situations.All products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.Review of the available information suggests that device interaction, device manipulation and target site anatomy may have contributed to the reported events.No further actions are required at this time.

• Brand Name: MICRUSFRAME COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6504564
• Report Number: 2954740-2017-00086
• Device Sequence Number: 14740
• Product Code: HCG
• UDI-Device Identifier: 10886704077909
• UDI-Public: (01)10886704077909(17)190930(10)S12422
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: MFR100829
• Device Lot Number: S12422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 05/11/2017; 05/22/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 87 YR