MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC402300

Device Problems Retraction Problem (1536); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient age, weight, medical history, race, and ethnicity were not provided.The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.Concomitant med products due to character limitation: 7f 25cm super sheath (medikit) sheath introducer, 35inch 180cm satsuki (apt) guidewire, 7f 100cm optimo (tokai medical) guiding catheter, prowler select plus 45° microcatheter, okay y-connector (goodman).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 1226348-2018-00527 & 1226348-2018-00528.

Event Description

A report was received that during a stent-assisted coil embolization of a dissecting vertebral artery aneurysm, after the 4mm x 23mm enterprise 2 (enc402300/10812127) stent was placed at the lesion and the coil embolization was planned, the stent was noted to be misaligned.The physician attempted to remove the stent but the distal marker got stuck and there was resistance felt when the stent was placed in the prowler select plus 45° microcatheter (unknown catalog and lot).The stent was replaced with another enterprise.After replacing the enterprise, ¿it was also removed once¿ and confirmed that there were no issues.Several coils were then placed in the aneurysm.The procedure was completed successfully without further issues or delay.There was no report of consequence or impact to the patient.The patient¿s vessel was heavily tortuous and moderately calcified.The products were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No visible product damage was noted prior to the event.A 7f 25cm super sheath (medikit) sheath introducer, a 35-inch 180cm satsuki (apt) guidewire, a 7f 100cm optimo (tokai medical) guiding catheter, and an okay y-connector (goodman) were also used for the case.The enterprise stent will not be returned for analysis.The whereabouts of the prowler select plus microcatheter is not known.No further information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Additional information received indicated that the physician partially deployed the stent at the desired position but the physician was not satisfied with the position and wished to recapture the device and reposition.The stent was ¿migrated off¿.The issue did not require that the prowler select plus microcatheter be removed with the enterprise stent; therefore, there was no loss of cerebral target position associated with the event.The replacement enterprise was recaptured successfully, repositioned, and the final position was satisfactory.There was good wall apposition between all areas of the stent and the vessel.There was nothing unusual noted about the enterprise system prior to use.There was no difficulty encountered during introduction of the catheter of the guidewire prior to attempted use of the device.There was also no difficulty tracking the microcatheter to the target site.Excessive manipulation/torqueing was not required prior to introduction of the device.There was no evidence of vessel damage, trauma, or dissection related to the use of the devices.The user did not apply excessive force at any time during the case.The event did not result in a procedural delay.The prowler select plus was discarded by the site and is not available for return.(b)(6).Complaint conclusion: as reported by a healthcare professional, during a stent-assisted coil embolization of a dissecting vertebral artery aneurysm, after the 4mm x 23mm enterprise2 (enc402300/10812127) stent was placed at the lesion and the coil embolization was planned, the stent was noted to be misaligned.The physician attempted to remove the stent but the distal marker got stuck and there was resistance felt when the stent was placed in the prowler select plus 45° microcatheter (unknown catalog and lot).The stent was replaced with another enterprise.After replacing the enterprise, ¿it was also removed once¿ and confirmed that there were no issues.Several coils were then placed in the aneurysm.The procedure was completed successfully without further issues or delay.There was no report of consequence or impact to the patient.The patient¿s vessel was heavily tortuous and moderately calcified.The products were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No visible product damage was noted prior to the event.A 7f 25cm super sheath (medikit) sheath introducer, a 35-inch 180cm satsuki (apt) guidewire, a 7f 100cm optimo (tokai medical) guiding catheter, and an okay y-connector (goodman) were also used for the case.Additional information received indicated that the physician partially deployed the stent at the desired position but the physician was not satisfied with the position and wished to recapture the device and reposition.The stent was ¿migrated off¿.The issue did not require that the prowler select plus microcatheter be removed with the enterprise stent; therefore, there was no loss of cerebral target position associated with the event.The replacement enterprise was recaptured successfully, repositioned, and the final position was satisfactory.There was good wall apposition between all areas of the stent and the vessel.There was nothing unusual noted about the enterprise system prior to use.There was no difficulty encountered during introduction of the catheter of the guidewire prior to attempted use of the device.There was also no difficulty tracking the microcatheter to the target site.Excessive manipulation/torqueing was not required prior to introduction of the device.There was no evidence of vessel damage, trauma, or dissection related to the use of the devices.The user did not apply excessive force at any time during the case.The prowler select plus was discarded by the site and is thus not available for evaluation.No further information was provided.The enterprise2 stent was not returned 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.The prowler select plus microcatheter was not returned for evaluation.Additionally, the sterile lot number is not known.No further analysis can be performed for complaints reported without a lot number and for which the associated products will not be returned.With the limited information available and without the products 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.Without a lot number to conduct a device history record review, it is not possible to determine if the reported failure could be related to the manufacturing process.The exact cause of the event could not be conclusively determined; however, there are procedural/handling and patient factors that 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 1226348-2018-00527 & 1226348-2018-00528.

• Brand Name: ENTERPRISE2 4MMX23MM NO TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 7334224
• MDR Text Key: 102227999
• Report Number: 1226348-2018-00527
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: ENC402300
• Device Lot Number: 10812127
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR