MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 12MM X 40CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR181240
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The micrusframe18 product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).Physical manufacturer: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The name of the initial reporter is unknown.The manufacturer representative was provided as the initial reporter name.Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.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
As reported by an affiliate, during a thoracic aortal stent-grafting and the coil embolization at the left subclavian artery, a micrisfram18s (mfr181240, s12858) was inserted in the left subclavian artery and the physician attempted to detached the coil.However, the green ready light was not on and it could not detach the coil.The micrusframe was not flushed to improve.Therefore, it was replaced with another product with another lot number.The procedure was successfully completed without further issues or delay.There was also no patient injury or complications reported.The product is not available for the investigation.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to and after the event.No unintended detachment was observed in the vessel or in the micro catheter.The patient¿s vessel was not torturous and heavily calcified.A micro catheter (progreat s, terumo), a y connector (okay, goodman) and an empower control cable were also used for this procedure.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information received indicated that the coil delivery system was successfully removed from the patient and the coil was still attached.Pre-deployment electrical check was performed.Complaint conclusion: as reported by an affiliate, during a thoracic aortal stent-grafting and the coil embolization at the left subclavian artery, a micrisfram18s (mfr181240, s12858) was inserted in the left subclavian artery and the physician attempted to detach the coil.However, the green ready light was not on and it could not detach the coil.The micrusframe was not flushed to improve.The coil delivery system was successfully removed from the patient and the coil was still attached.Another product with from another lot was used.The procedure was successfully completed without further issues or delay.There was also no patient injury or complications reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and constant flush had been maintained at all time.Pre-deployment electrical check was performed.No visible defect/damage was noted on the products prior to and after the event.No unintended detachment was observed in the vessel or in the micro catheter.The patient¿s vessel was not torturous and heavily calcified.A micro catheter (progreat s, terumo), a y connector (okay, goodman) and an empower control cable were also used for this procedure.No further information is available.The micrusframe18 product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Without the device returned for investigation, the reported event of failure to detach could not be confirmed.However, based on the information available for review, there are vessel characteristics (calcification) that may have contributed to the event reported.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: MICRUSFRAME18 12MM X 40CM
• 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: 7319840
• Report Number: 3008114965-2018-00554
• Device Sequence Number: 151865
• Product Code: KRD
• UDI-Device Identifier: 10886704078098
• UDI-Public: 10886704078098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: MFR181240
• Device Lot Number: S12858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR