MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EU ENT4.5MMD 14MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC451400

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient 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 device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.Device manufacture date: not available 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by a healthcare professional, it was reported that the stent of a 4.5 mmd 14 mml enterprise (enc451400, 10989442) deployed in y connector when it was withdrawn across the rebar microcatheter (mc).After the stent deployed partly in the target position, the physician found that the stent could not deploy well due to the ¿harder¿ blood plaques.The user then decided to withdraw the stent into the catheter and pull the stent and catheter back out of the patient¿s body.But when the stent crossed the microcatheter, the physician found the stent was hard to move.Then he pulled the guiding wire more heavily, however the wire separated from the stent system, so the stent deployed in y connector.The target position was lost.Finally, the physician used a competitor¿s product and completed the procedure.The patient was not injured in the operation.The stent deployed outside of the patient¿s body.There was no significant procedural delays due to the events.This procedure was for an open blocked blood vessel.Additional information indicated that the device was inspected for damage prior to use.Adequate flush been maintained through the devices.The tip of the introducer sat correctly in the rhv and microcatheter hub.The introducer was placed securely in the hub prior to attempting to advance the delivery wire.No additional intervention was done when the device was removed from the patient.

Manufacturer Narrative

Product complaint (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, the stent of a 4.5mmd 14mml enterprise (enc451400, 10989442) deployed in the y connector when it was withdrawn across the rebar microcatheter (mc).After the stent deployed partly in the target position, the physician found that the stent could not deploy well due to the ¿harder¿ blood plaques.The user then decided to withdraw the stent into the catheter and pull the stent and catheter back out of the patient¿s body.But when the stent crossed the microcatheter, the physician found the stent was hard to move.Then he pulled the guiding wire more heavily, however the wire separated from the stent system, so the stent deployed in y connector.The target position was lost.Finally, the physician used a competitor¿s product and completed the procedure.The patient was not injured in the operation.The stent deployed outside of the patient¿s body.There was no significant procedural delays due to the events.This procedure was for an open blocked blood vessel.Additional information indicated that the device was inspected for damage prior to use.Adequate flush been maintained through the devices.The tip of the introducer sat correctly in the rhv and microcatheter hub.The introducer was placed securely in the hub prior to attempting to advance the delivery wire.No additional intervention was done when the device was removed from the patient.A non-sterile unit eu ent4.5mmd 14mml wno dstl tp and a rebar-18 microcatheter (non j&j product) were received inside of a pouch.The eu ent4.5mmd 14mml wno dstl tp was inspected the results are as follows.The delivery wire and the introducer were inspected, and they were found in good normal condition.The stent was found inside the hub of the rebar-18 microcatheter (non j&j product), after that the stent was inspected under microscope trough the hub, and it was found without damage, however it was found deployed from the introducer.Dry blood residues were observed on the hub of the rebar-18 microcatheter (non j&j product).The functional analysis could not be performed due to the stent was found deployed from the introducer and it is necessary that the stent is still inside of the introducer tube to perform the functional analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 10989442.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint reported by the customer ¿stent - deployment difficulty-premature/in microcatheter hub¿ was confirmed, since during the visual inspection it was noted that the stent was deployed from the device and stuck inside the hub of the rebar-18 microcatheter (non j&j product).The complaint reported by the customer ¿stent deployment difficulty-partial deployment¿ was confirmed, since during the visual inspection it was noted that the stent was deployed from the device and stuck inside the hub of the rebar-18 microcatheter (non j&j product).However, the exact circumstances surrounding the observed stent deployment could not be conclusively determined based on the condition of the returned device.The complaint reported by the customer ¿delivery wire withdrawal difficulty through microcatheter with loss of cerebral target¿ could not be evaluated due to the condition of the received unit.Neither the analysis nor the mre suggest that the failure reported by the costumer could be related to the manufacturing process.Deployment difficulty is a known potential product failure associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Of note, the device was being used off-label to treat carotid artery stenosis.According to the ifu, the enterprise stent is intended for use with occlusive devices in the treatment of intracranial aneurysms and is not intended as a stand-alone device.Assignment of root cause for the events remains speculative and inconclusive, based on the information provided.However, however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics (¿harder¿ blood plaques¿), device selection, and the concomitant microcatheter, may have contributed to the reported issue.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: EU ENT4.5MMD 14MML WNO DSTL TP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9118329
• MDR Text Key: 160316849
• Report Number: 1226348-2019-00990
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Catalogue Number: ENC451400
• Device Lot Number: 10989442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC REBAR MICROCATHETER