MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EU ENT4.5MMD 28MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452800

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Information regarding patient's date of birth, weight, height, relevant medical history, race, and ethnicity was not reported.(b)(6).(b)(4).The product is not available for evaluation and testing; however, we will review the manufacturing and quality records as applicable per our internal procedure.These records will comprise our lots/batches history records, which were created during the manufacturing of the device.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.

Event Description

As reported by a healthcare professional, a (b)(6) male patient underwent off-label endovascular treatment of a large vertebrobasilar artery occlusion with a 4.5mm x 28mm enterprise (enc452800/10666120) and became paralyzed three days later.Due to ¿no angiogram review offered¿, the physician speculated that the event may be related to stent thrombosis or displacement.The event is reportedly ongoing.The patient initially presented with a large occlusion on the left side of the brain, accompanied by renal insufficiency and ¿tongue root fall¿, and a thrombectomy was subsequently performed.The enterprise stent was then placed via a prowler select plus microcatheter 150/5cm (606s255x/17508750) in the basilar artery.It was reported that the procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.The stent remains implanted in the patient and is thus not available for evaluation.No further information was provided.

Manufacturer Narrative

Product complaint #: (b)(4).Additional information received on 18-mar-2019 indicated that the enterprise stent was implanted on (b)(6) 2017 and the paralysis occurred on (b)(6) 2017.It is unknown if the 50-year-old patient experienced symptoms immediately following the case, but the patient developed paralysis of both legs three days post-procedure.It was not reported if the paralysis required medical and/or surgical intervention, but the event did not result in hospitalization or prolongation of hospitalization.The paralysis has not resolved.It was not reported if the patient initially presented with a stroke prior to the procedure, but the patient was reportedly ¿free to move¿ prior to the procedure.The indication for the off-label use of the enterprise stent was spontaneous thrombosis, and the cause of the thrombus formation is unknown.There was no evidence of a device malfunction (i.E.Deployment issue) or procedural complication.The stent was implanted in the correct position and well-apposed to the vessel wall.The physician¿s opinion that the paralysis may be due to stent thrombosis or stent displacement was not based on angiograms or other testing but was only speculation of potential root causes.Head computed tomography (ct) was not performed, and there was no evidence of ischemia/stroke that the physician felt could be related to the stent.The patient was on 300mg of preoperative and intraoperative heparin and postoperative aspirin and pumped tirofiban.Antiplatelet effectiveness was not tested prior to the procedure.It was not reported if baseline and post-heparin activated clotting times (acts) were monitored.The explanation of ¿tongue root fall¿ was not provided, but it was further stated that ¿the root suffix is not associated with paralysis.¿ the concomitant devices functioned as expected.No further information could be obtained.Initial reporter phone: (b)(6).Initial reporter occupation: director of intervention.Complaint conclusion: as reported by a healthcare professional, a 50-year-old male patient underwent off-label endovascular treatment of a large vertebrobasilar artery occlusion with a 4.5mm x 28mm enterprise (catalog: enc452800/lot: 10666120) and developed paralysis of both legs three days later.It was not reported if the event required medical and/or surgical intervention, but the result did not result in hospitalization or prolongation of hospitalization.The last report received indicated that the paralysis has not resolved.The physician felt that the event may be related to stent thrombosis or stent displacement, but this opinion was not based on angiograms or other testing.The patient initially presented with a large occlusion on the left side of the brain, accompanied by renal insufficiency and ¿tongue root fall¿, and a thrombectomy was subsequently performed.The enterprise stent was then placed via a prowler select plus microcatheter 150/5cm (catalog: 606s255x/lot: 17508750) in the basilar artery.It was reported that the procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.It was not reported if the patient initially presented with a stroke prior to the procedure, but the patient was reportedly ¿free to move¿ prior to the procedure.It is unknown if the patient experienced symptoms immediately following the case, but the patient developed paralysis three days post-procedure.The indication for the off-label use of the enterprise stent was spontaneous thrombosis, and the cause of the thrombus formation is unknown.There was no evidence of a device malfunction (i.E.Deployment issue) or procedural complication.The stent was implanted in the correct position and well-apposed to the vessel wall.Head computed tomography (ct) was not performed, and there was no evidence of ischemia/stroke that the physician felt could be related to the stent.The patient was on 300mg of preoperative and intraoperative heparin and postoperative aspirin and pumped tirofiban.Antiplatelet effectiveness was not tested prior to the procedure.It was not reported if baseline and post-heparin activated clotting times (acts) were monitored.The explanation of ¿tongue root fall¿ was not provided, but it was further stated that ¿the root suffix is not associated with paralysis¿.The concomitant devices functioned as expected.No further information could be obtained.The enterprise stent remains implanted in the patient and is thus not available 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.Neurologic deficit is a known potential complication associated with the enterprise stent and is listed in the instructions for use (ifu) as such.The physician surmised that stent thrombosis or displacement may have contributed to the paralysis; however, a head ct scan was not performed to confirm this speculation.With the limited information available and without diagnostic testing, it is not possible to determine the cause of the paralysis that occurred.It is very unusual that the patient would suffer from bilateral paralysis (paraplegia), with no other symptoms of stroke.Since no diagnostic testing was performed, it is not possible to confirm if there was thrombosis or hemorrhage that may have caused the event.Pre and post anti-platelet medications, as well as intraoperative heparin were administered, but antiplatelet effectiveness was not tested prior to the procedure and it was not reported if baseline and post-heparin activated clotting times (acts) were monitored.The root cause of the event cannot be conclusively determined; however, patient, procedural, and/or pharmaceutical factors, as well as the off-label use of the enterprise, may have contributed to the reported paralysis.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.Although the stent was used as an off-label attempt to treat the thrombus, the symptoms that occurred post-procedure may have been a result of continued thrombosis related to the pre-existing condition.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 ENT4.5MMD 28MML 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: 8422117
• MDR Text Key: 138838611
• Report Number: 1226348-2019-00846
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Catalogue Number: ENC452800
• Device Lot Number: 10666120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 50 YR