MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX16MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENF401612

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient age/date of birth, gender, weight, height, medical history, race, and ethnicity was not reported.The product is available for evaluation and testing; however, it has not been received to date.Additional information will be submitted within 30 days of receipt.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 company is seeking this information through the event investigation.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by a healthcare professional, the 4mm x 16mm enterprise 2 (enf401612/10839507) stent vascular reconstruction device could not be recaptured.The physician deployed half of the stent and attempted to recapture the stent for repositioning without success.The physician removed the system from the guiding catheter without the need for additional intervention.The stent prematurely deployed outside of the patient¿s body following removal.The procedure was completed successfully, and no patient complications occurred as a result of the event.The surgery was delayed 30 minutes due to the event.As the physician could not locate the deployed stent following the procedure, only the delivery wire will be returned for evaluation.No further information was provided.

Manufacturer Narrative

Product complaint # (b)(4).[complaint conclusion]: as reported by a healthcare professional, the 4mm x 16mm enterprise2 (enf401612/10839507) stent could not be recaptured.The physician deployed half of the stent and attempted to recapture the stent for repositioning but was unsuccessful.The physician removed the system from the patient without need for additional intervention.The procedure was completed successfully, and no patient complications occurred as a result of the event.The surgery was delayed 30 minutes due to the event, but it was not reported if the surgical delay was considered clinically significant.The stent deployed outside of the patient¿s body following removal and the physician was unable to locate the deployed stent to return for evaluation.The intended procedure/target vessel location and relevant anatomical information is unavailable.The stent/stent delivery system and microcatheter did not appear damaged prior to use, during the procedure, or after withdrawal.The size/brand microcatheter used was not reported.The device was prepped according to the instructions for use (ifu) instructions.There was no difficulty during introduction of the catheter over the guidewire prior to the attempted use of this device.There was also no difficulty tracking the microcatheter to the target site or excessive manipulation/torqueing required prior to introduction of this device.The user verified that the introducer was fully seated and secured in the hub and the rotating hemostatic valve (rhv) was opened to allow the passage of the device.An adequate and continuous flush was maintained through the microcatheter.There was no difficulty encountered advancing the device through the microcatheter.The stent was positioned for deployment by aligning the stent positioning marker of the delivery wire with the target site, as indicated in the ifu.It was not reported if the user exceeded the recapturability limit; however, it was stated that the user kept the stent stable with tension on the delivery wire when advancing the microcatheter over the stent during recapture.No further information could be obtained.The delivery wire of the 4mm x 16mm enterprise2 was received inside of a pouch.Upon receipt of the complaint sample, visual inspection was conducted.The distal end of the delivery wire was found kinked.The introducer and stent were not returned for evaluation and testing.The delivery wire was then examined under a microscope and the kinked condition observed during visual inspection was confirmed.Functional testing could not be performed since the introducer and stent were not returned for analysis.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 inability to recapture the stent could not be evaluated without the return of the introducer and stent.The event description documents that the stent deployed during post-procedural handling, and the physician could not locate the stent for return.Functional testing could not be performed to determine potential causes of the inability to recapture; however, inability to recapture is a known potential product issue associated with the use of the enterprise2 stent.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting should it be encountered during use.The ifu states the following: ¿if stent positioning is not satisfactory, the stent may be recaptured and repositioned.The stent may be recaptured until the point where the proximal end of the stent positioning marker is aligned with the infusion catheter distal marker band (recapturability limit).If stent repositioning is required, gently advance the infusion catheter over the deployed stent (do not pull the stent back into the infusion catheter), reposition the system, and re-deploy the stent in the new location.Note: when advancing the infusion catheter over the stent during recapture, it may be necessary to keep the stent stable with tension on the delivery wire.Caution: if resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.Caution: the stent may be fully recaptured once.¿ 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 minimal information available for review and evidence presented by the sample article; however, it is possible that procedural and handling factors, including device manipulation and interaction with the concomitant microcatheter, 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).The purpose of this mdr submission is to report that the product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #: (b)(4).Additional information received indicated that the physician successfully delivered the stent to the target location, but when he tried to recapture it to reposition the stent, he failed.The intended procedure/target vessel location and relevant anatomical information is unavailable.The stent/stent delivery system or microcatheter did not appear damaged prior to use, during the procedure, or after withdrawal.The size/brand microcatheter used was not reported.The device was prepped according to the instructions for use (ifu) instructions.There was no difficulty during introduction of the catheter over the guidewire prior to the attempted use of this device.There was also no difficulty tracking the microcatheter to the target site or excessive manipulation/"torquing" required prior to introduction of this device.It was verified that the introducer was fully seated and secured in the hub.It is not known if the device moved out forward of the introducer during insertion through the y-connector or in the hub.The rotating hemostasis valve (rhv) was opened to allow the passage of the device.An adequate and continuous flush was maintained through the microcatheter.There was no difficulty encountered advancing the device through the microcatheter.The stent was positioned for deployment by aligning the stent positioning marker of the delivery wire with the target site, as indicated in the ifu.It was not reported if the user exceeded the recapturability limit.When advancing the microcatheter over the stent during recapture, the user kept the stent stable with tension on the delivery wire.If resistance was felt during recapture, it was not reported if the user withdrew the microcatheter slightly to unsheathe the stent (without excessing the recapture limit) and attempt to recapture the stent again.It was also not reported how many times the user attempted to recapture the stent.It is unknown if the device was able to be removed from the microcatheter or if the event required removal of the microcatheter.It is also unknown if there were any difficulties removing the microcatheter or the stent from the patient or if additional intervention was required.It was not reported whether the same microcatheter was used to complete the procedure.It is unknown if the user applied undue force at any time when handling the device.It was not reported if the delay in procedure was considered clinically significant.No further information could be obtained.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 product is available for evaluation and testing; however, it has not been received to date.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX16MM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8257379
• MDR Text Key: 133526223
• Report Number: 1226348-2019-00823
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075332
• UDI-Public: 10886704075332
• 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,Followup,Followup
• Report Date: 01/03/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Catalogue Number: ENF401612
• Device Lot Number: 10839507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/17/2019
• Supplement Dates Manufacturer Received: 01/29/2019; 02/21/2019; 04/02/2019
• Supplement Dates FDA Received: 02/13/2019; 03/07/2019; 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1