MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EU 4.5X14MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC451412

Device Problems Premature Activation (1484); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2018

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.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, 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.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, during a stent-assisted coil embolization of an intracranial aneurysm, the 4.5 x 14mm enterprise (enc451412/10895544) stent vascular reconstruction device would not deploy when it reached the aneurysm position.The physician pulled it back and found it had prematurely detached during withdrawal.The device was replaced, and the procedure was completed successfully without further incident or delay.It is not known if the event resulted in loss of cerebral target position or if the same microcatheter was used to complete the procedure.No patient complications occurred as a result of the event.The surgery was not delayed due to the event.There were no difficulties removing the microcatheter or the stent from the patient and no additional intervention was required.The complaint product was new and stored/handled according to the instructions for use (ifu).The device was packaged securely as expected.No damage was noted to the device packaging or shipping container.The stent/stent delivery system did not appear damaged.The concomitant microcatheter was not visibly damaged.The procedure was conducted in accordance with the ifu and a constant flush was maintained.There was no difficulty encountered during introduction of the catheter over the guidewire prior to the attempted use of this device.The user verified that the introducer was fully seated and secured in the hub; however, it is not known if the device moved out forward of the introducer during insertion thru the y-connector or in the hub.It is also not known if the rotating hemostasis valve (rhv) was opened to allow the passage of the device.There was no difficulty encountered advancing the device through the unspecified microcatheter.The stent was positioned for deployment by aligning the stent positioning marker of the delivery wire with the target site as per the ifu.It is not known how many times the user attempted to recapture the stent and if the user exceeded the recapturability limit.The user did not apply undue force at any time.The product will be returned for evaluation.No further information could be obtained.

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.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.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.

Manufacturer Narrative

Product complaint # (b)(4).[complaint conclusion].As reported by a healthcare professional, during a stent-assisted coil embolization of an intracranial aneurysm, the 4.5 x 14mm enterprise (enc451412/10895544) stent vascular reconstruction device would not deploy when it reached the aneurysm position.The physician pulled it back and found it had prematurely deployed during withdrawal.The device was replaced, and the procedure was completed successfully without further incident or delay.It was not reported if the event resulted in loss of cerebral target position or if the same microcatheter was used to complete the case.No patient complications occurred as a result of the event.The surgery was not delayed due to the event.There were no difficulties removing the microcatheter or the stent from the patient and no additional intervention was required.The complaint product was new and stored/handled according to the instructions for use (ifu).The device was packaged securely as expected.No damage was noted to the device packaging or shipping container.The stent/stent delivery system and concomitant microcatheter did not appear damaged.The procedure was conducted in accordance with the ifu and a constant flush was maintained.There was no difficulty encountered during introduction of the catheter over the guidewire prior to the attempted use of this device.The user verified that the introducer was fully seated and secured in the hub; however, it was not reported if the device moved out forward of the introducer during insertion thru the y-connector or in the hub.It is also not known if the rotating hemostasis valve (rhv) was opened to allow the passage of the device.There was no difficulty encountered advancing the device through the unspecified microcatheter.The stent was positioned for deployment by aligning the stent positioning marker of the delivery wire with the target site as instructed in the ifu.It was not reported how many times the user attempted to recapture the stent or if the user exceeded the recapturability limit.The user did not apply undue force at any time.No further information could be obtained.A non-sterile enterprise device was received inside of a pouch.Upon receipt of the complaint device, visual inspection was conducted.The delivery wire was undamaged.The stent and introducer tube were not returned for evaluation.There were no other visual anomalies observed during the visual inspection.Functional testing could not be performed since the stent and introducer were not returned for evaluation.The stent must still be inside of the introducer in order to conduct functional 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 customer report of deployment difficulty and inability to recapture could not be evaluated since the stent and introducer were not returned and these components are necessary in order to conduct functional testing.The customer report of premature deployment was confirmed; however, the exact circumstances surrounding the stent deployment could not be conclusively determined based on the condition of the returned device.Functional testing could not be performed to determine potential root causes of the event.Deployment difficulty, inability to recapture, and premature deployment are known potential product issues associated with the use of the enterprise stent and is listed in the ifu as such.The ifu contains several cautions relating to these situations, including instructions for troubleshooting the situations should they be encountered during use.The ifu states the following: ¿position the stent for deployment by aligning the stent positioning marker of the delivery wire with the target site.If stent positioning is satisfactory, carefully retract the infusion catheter, while maintaining the position of the delivery wire, to allow the stent to deploy across the neck of the aneurysm.The stent will expand as it exits the infusion catheter.Warning: do not detach the stent if it is not properly positioned in the vessel.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 markerband (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 un-sheath the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.Caution: the stent may be fully recaptured once.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.¿ 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 provided and the evidence presented by the returned device; 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.

• Brand Name: EU 4.5X14MM STENT 12 MM DW TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8218888
• MDR Text Key: 132980521
• Report Number: 1226348-2019-00812
• 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,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Catalogue Number: ENC451412
• Device Lot Number: 10895544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1