MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX30MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	ENF403000
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint conclusion: as reported by a health care professional, during a stent-assisted coil embolization of a wide-necked basilar tip aneurysm, a 4mm x 30mm enterprise 2 stent (enf403000/10882814) became stuck in the unspecified microcatheter.The enterprise 2 stent and microcatheter were easily removed from the patient, resulting in a loss of cerebral target position, and replaced with new devices.The surgery was not delayed due to the event.No patient complications occurred as a result of the event.The device was used and prepped according to the instructions for use (ifu).The enterprise 2 stent and the unspecified microcatheter did not kink or bend at any time.No visible product damage was noted when the product was removed from the patient.An adequate continuous flush was maintained through the microcatheter.The user did not apply excessive force at any time during the case.No further information was provided.The enterprise 2 stent was discarded and is thus not available for evaluation.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.With the limited information available and without the product and concomitant microcatheter available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a health care professional, during a stent-assisted coil embolization of a wide-necked basilar tip aneurysm, a 4mm x 30mm enterprise 2 stent (enf403000/10882814) became stuck in the unspecified microcatheter.The enterprise 2 stent and microcatheter were easily removed from the patient, resulting in a loss of cerebral target position, and replaced with new devices.The surgery was not delayed due to the event.No patient complications occurred as a result of the event.The device was used and prepped according to the instructions for use (ifu).The enterprise 2 stent and the unspecified microcatheter did not kink or bend at any time.No visible product damage was noted when the product was removed from the patient.An adequate continuous flush was maintained through the microcatheter.The user did not apply excessive force at any time during the case.The product was discarded and is thus not available for evaluation.No further information was provided.

• Brand Name: ENTERPRISE2 4MMX30MM NO TIP
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 7730987
• Report Number: 1226348-2018-00663
• Device Sequence Number: 1588761
• Product Code: NJE
• UDI-Device Identifier: 10886704075387
• UDI-Public: 10886704075387
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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: 07/28/2020
• Device Catalogue Number: ENF403000
• Device Lot Number: 10882814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/30/2018
• 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