MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME14 6MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR140615
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient identifier and date of birth were not provided.Procode is krd/hcg.Initial reporter phone and email are not available.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).[conclusion]: the healthcare professional reported via the sterling study that during the endovascular coil embolization targeting a right bifurcated aneurysm on the posterior cerebral artery (pca) with the following dimension: 6.5 mm height, 3.8 mm dome, 1.9 mm neck, a maximum diameter of 6.5 mm, a derived dome to neck ratio of 2.0 mm, and parent vessel diameter of 2.5mm, the 6mm x 15cm micrusframe 14 coil (mfr140615 / s14089) delivered to the target site via the headway® 17 advanced microcatheter (microvention), but the coil did not conform to the aneurysm shape and was not implanted.It was reported that the aneurysm was irregularly shaped, and this may have contributed to the reported coil conformability issue.The micrusframe coil was not able to conform to the aneurysm wall, there was no report of positioning difficulty when the coil was delivered to the target lesion; the irregular shape of the aneurysm did not affect the positioning of the coil in the aneurysm.The coil was not deployed in an unintended site that is proximal or distal to the target lesion.There was no report of any patient consequence or adverse event.It was reported that the device was discarded and not available to be returned for evaluation.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (s14089) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.In addition, the complaint documented that there was no positioning difficulty once the 6mm x 15cm micrusframe 14 coil was delivered to the target site; the aneurysm was also reported to be irregularly shaped, which may have contributed to the reported coil conformability issue.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 for statistical signals and corrective/preventive action may be triggered at a later time.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.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
The healthcare professional reported via the sterling study that during the endovascular coil embolization targeting a right bifurcated aneurysm on the posterior cerebral artery (pca) with the following dimension: 6.5 mm height, 3.8 mm dome, 1.9 mm neck, a maximum diameter of 6.5 mm, a derived dome to neck ratio of 2.0 mm, and parent vessel diameter of 2.5mm, the 6mm x 15cm micrusframe 14 coil (mfr140615 / s14089) delivered to the target site via the headway® 17 advanced microcatheter (microvention), but the coil did not conform to the aneurysm shape and was not implanted.It was reported that the aneurysm was irregularly shaped, and this may have contributed to the reported coil conformability issue.The micrusframe coil was not able to conform to the aneurysm wall, there was no report of positioning difficulty when the coil was delivered to the target lesion; the irregular shape of the aneurysm did not affect the positioning of the coil in the aneurysm.The coil was not deployed in an unintended site that is proximal or distal to the target lesion.There was no report of any patient consequence or adverse event.It was reported that the device was discarded and not available to be returned for evaluation.

• Brand Name: MICRUSFRAME14 6MM X 15CM
• 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: 8672908
• Report Number: 3008114965-2019-01031
• Device Sequence Number: 245148
• Product Code: KRD
• UDI-Device Identifier: 10886704078005
• UDI-Public: 10886704078005
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

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: 04/30/2020
• Device Catalogue Number: MFR140615
• Device Lot Number: S14089
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 104