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

Catalog Number	ENF403000
Medical Device Problem Codes	Premature Activation (1484); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant med products due to character limitation: 6f sheath, 6f envoy guiding catheter, axium (medtronic) coils.Initial reporter - the customer contact information, including occupation, phone, and fax number, was not reported.Complaint conclusion: as reported by a healthcare professional, during a stent-assisted coil embolization of a recurrent mildly tortuous left ophthalmic artery aneurysm, the 4 mm x 30 mm enterprise 2 no tip (enf403000/10689189) stent was loaded, flushed, and advanced through the 0.021¿ rapid transit 150 cm (601251x/30042646) dual marker microcatheter, but resistance was encountered about halfway through the microcatheter and the stent could no longer be advanced.The stent became stuck in the microcatheter hub during removal; therefore, the microcatheter was removed from the patient.The microcatheter and stent were replaced, and target position was easily re-obtained.The enterprise 2 stent was implanted across the neck of the aneurysm and four competitor coils were placed in the aneurysm.Post angiography revealed good result and the case was concluded.No patient complications occurred as a result of the event.The surgery was delayed 5-10 minutes due to the event.The patient did well post-op and was discharged the following day.The right femoral artery was accessed with a 6f sheath.The target aneurysm was previously coiled with competitor coils.No visible product damage was noted prior to the event.An adequate continuous flush was maintained through the catheter.There was no difficulty encountered during introduction of the catheter over the guidewire prior to the attempted use of the device.A 6f envoy guiding catheter was used in the case.No further information was provided.A non-sterile enterprise2 4 mm x 30 mm no tip and rapidtransit dual marker 150 cm microcatheter were received inside of a pouch.The delivery wire was inspected, and no damage was observed.The introducer was not returned for evaluation.The stent was found deployed in the hub of the microcatheter.The stent was removed from the microcatheter hub and no damage was noted to the stent.No additional damage was observed.Functional testing could not be performed since the introducer was not returned for evaluation and the stent was found deployed in the microcatheter hub.Although the stent was removed from the microcatheter, per procedure, the stent must still be inside of the introducer tube to perform functional examination.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.The reported customer complaint ¿delivery wire- impeded in microcatheter with loss of cerebral target position¿ could not be evaluated since the introducer was not returned and is needed to perform functional testing with the microcatheter.The reported complaint of ¿stent deployment difficulty-premature/in microcatheter hub" was confirmed since the stent was found deployed in the hub of the microcatheter.Impeded in microcatheter and premature deployment are known potential issues associated with the enterprise 2 stent.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.The device did not present any obvious indication of manufacturing defect or anomaly that could have contributed to the event as reported.Neither the product analysis nor the device history review suggests that the failure could be related to the manufacturing process of the unit.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and the evidence presented by the sample article; however, it is possible that procedural and handling factors 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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the reported complaint and the associated manufacturer report numbers are 1226348-2018-00734.
Event or Problem Description
As reported by a healthcare professional, during a stent-assisted coil embolization of a recurrent left ophthalmic artery aneurysm, the 4 mm x 30 mm enterprise 2 no tip (enf403000/10689189) stent was loaded, flushed, and advanced through the 0.021¿ rapid transit 150 cm (601251x/30042646) dual marker microcatheter, but resistance was encountered about halfway through the microcatheter and the stent could no longer be advanced.The stent became stuck in the microcatheter hub during removal; therefore, the microcatheter was removed from the patient.The microcatheter and stent were replaced, and target position was easily re-obtained.The enterprise 2 stent was implanted across the neck of the aneurysm and four competitor coils were placed in the aneurysm.Post angiography revealed good result and the case was concluded.No patient complications occurred as a result of the event.The surgery was delayed 5-10 minutes due to the event.The patient did well post-op and was discharged the following day.The right femoral artery was accessed with a 6f sheath.The target aneurysm was previously coiled with competitor coils one year prior.The vessel tortuosity was low.No visible product damage was noted prior to the event.An adequate continuous flush was maintained through the catheter.There was no difficulty encountered during introduction of the catheter over the guidewire prior to the attempted use of the device.A 6f envoy guiding catheter and the rapid transit microcatheter were advanced past the coiled aneurysm for stent placement, but the enterprise became stuck in the microcatheter.Photo provided by the sales representative appears to confirm the stent stuck in the hub of the microcatheter.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: 7876761
• Report Number: 1226348-2018-00733
• Device Sequence Number: 2217636
• Product Code: NJE
• UDI-Device Identifier: 10886704075387
• UDI-Public: 10886704075387
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/23/2018

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: 04/28/2019
• Device Catalogue Number: ENF403000
• Device Lot Number: 10689189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 113