MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM; CNV ENTERPRISE SES (NJE)

Catalog Number ENC401600

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bradycardia (1751); Facial Nerve Paralysis (1846); Transient Ischemic Attack (2109)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

The complaint received states that this (b)(6) study patient underwent treatment for a basal artery aneurysm and approximately four months post index procedure, reported dysarthria and facial paralysis.(b)(6) was enrolled in study on (b)(6) 2016 after pre-treatment angiogram revealed a posterior circulation, unruptured, saccular aneurysm location in the mid 1/3 of basilar artery.Index procedure was conducted on (b)(6) 2016 with an enterprise stent (enc401600/10546412).This is a (b)(6) with pmh significant for arterial htn (currently known).Previous smoker.Current medications include simvastatin, metoprolol, ramipril, and levetiracetam.Nkda.Post-index surgery medications include asa and clopidogrel.There were no reports of reduction in flow, concerns with parent vessel patency, stenosis or thrombosis as well as no reports of intra-procedural or post-procedural complications.Approximately four months post index procedure; the site reported that on (b)(6) 2016 patient experienced dysarthria and facial paralysis.This was a new serious neurological event, requiring inpatient hospitalization/prolongation of existing hospitalization.Event was reported to be mild in severity.Ct and mri evaluations were conducted, although no findings were reported.Nihss was performed with total score 0 (indicating no abnormality/normal); mrs score of 0 (no symptoms) investigators assessment of events: unlikely related to codman study device or any other devices used, unlikely related to procedure and unlikely related to patient¿s underlying condition (aneurysm).Serious injury occurred as a result of the event.Events reported as resolved with no reported residual effects.(b)(4).(b)(4) packaging: l/n 10546412.(b)(4) did review the device history records relative to the manufacturing, inspecting and packaging of the above mentioned lot.The device history record review also included a review of the certificate of conformance received from specialty coatings systems and nitinol devices and components, along with (b)(4) internal receiving inspection records for the stents issued to the complaint lot.The history records indicate this product was final inspection tested at (b)(4) and was determined to be acceptable.While not specifically listed in the ifu, dysarthria and facial paralysis do fall within the category of neurologic deficits, and that is referenced within the enterprise ifu as known potential adverse events associated with the use of the device.All products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.Review of the information suggests that site characteristics, location and size, medication regimen and underlying disease factors may have contributed to the reported events.This is an initial/final report.Concomitant medical products and therapy dates: penumbra guidewire, penumbra distal access catheter.(b)(4).

Event Description

(b)(6) was enrolled in study on (b)(6) 2016 after pre-treatment angiogram revealed a posterior circulation, unruptured, saccular aneurysm location in the mid 1/3 of basilar artery.Index procedure was conducted on (b)(6) 2016 with an enterprise stent (enc401600/10546412).There were no reports of reduction in flow, concerns with parent vessel patency, stenosis or thrombosis as well as no reports of intra-procedural or post-procedural complications.Site reported that on (b)(6) 2016 patient experienced dysarthria and facial paralysis.This was a new serious neurological event, requiring inpatient hospitalization/prolongation of existing hospitalization.Event was reported to be mild in severity.Assessments conducted: ct and mri evaluations were conducted (finding pending from site) nihss was performed with total score 0 (indicating no abnormality/normal); mrs score of 0 ( no symptoms).Investigators assessment of events: unlikely related to codman study device or any other devices used, unlikely related to procedure and unlikely related to patient's underlying condition(aneurysm).Serious injury occurred as a result of the event.Events reported as resolved with no residual effects (date pending).(b)(6) with pmh significant for arterial htn (currently known).Previous smoker.Current medications include simvastatin, metoprolol, ramipril, and levetiracetam.Nkda.Post-index surgery medications include asa and clopidogrel.

Manufacturer Narrative

(b)(4).Additional information was received via the case report form on 12/03/2016: coils that were implanted during the index procedure on (b)(6) 2016 included 2 stryker helical nano coils and 1 codman xtrasoft coil (640cs2525/c11530).Medical history included hypertension and dyslipidemia.It was previously reported that on (b)(6) 2016 the patient experienced dysarthria and facial paralysis.The events were updated in the crf to mild dysarthria, syncope, and bradycardia that required inpatient hospitalization for approximately 8 days.It was reported that events resolved with no residual effects on (b)(6) 2016, the same day as symptom onset.Ct scans and mri was performed; however, results were not reported.According to the investigator, the events were unrelated to device, procedure, or underlying disease.At the time of the 6 month follow-up, angiogram was performed on (b)(6) 2016, and revealed that the coil mass position was maintained within the sac, parent artery was patent, and the aneurysm was 100% occluded.There was no evidence of thrombosis or parent vessel stenosis and there was complete stent coverage across the aneurysm neck.

Manufacturer Narrative

Additional information was received on 1/30/2017.The event that occurred on (b)(6) 2016 was documented as a tia in the study case report form instead of the symptoms as previously documented.This does not change the mdr reportability or baseline conclusion of the complaint.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: CNV ENTERPRISE SES (NJE)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; 325 paramount dr; raynham, MA 02767 ; 5088288374
• MDR Report Key: 5703746
• MDR Text Key: 46717193
• Report Number: 1226348-2016-00101
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2018
• Device Catalogue Number: ENC401600
• Device Lot Number: 10546412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 06/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/07/2016; 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 50