MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISEENC

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This mdr is being submitted for the 10 events of inaccurate stent placement.There was no specific device, procedure or event information provided and no additional information could be obtained from the author.This submission is related to a literature article discovered in an effort to support the cer submission process, as such, the associated time frame of event dates includes but is not limited to 20 years.These articles are being reviewed on a monthly basis for safety signals and will be followed by monthly trending assessments as well as pms reviews.Date of event, product code, and lot number not available.Udi: unknown part number, attempts to obtain product part number were unsuccessful, udi unavailable.Literature article attached to mdr: wataro tsuruta et al.(2013).Analysis of closed-cell intracranial stent characteristics using cone-beam computed tomography with contrast material.Neurol med chir (tokyo) 53, 403-408, 2013.Conclusion: the device was not available for analysis.In addition, the lot number was not provided; therefore, a dhr could not be performed.Inaccurate placement of the stent, stent migration, incomplete expansion, stent kink, and reshaping of the vessel are known events that can occur with use of the enterprise stent.Inadequate radiopacity is not an expected event related to the enterprise stent.The root cause of the events cannot be determined based on the minimal information provided in the article; however, procedural/handling factors may have contributed to the events.There is no current safety signal identified related to the reported events based on review of complaint history for the device.Since there was no evidence to suggest the events was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.This is 1 of 6 mdr reports being submitted for this literature article with reference numbers of 1226348-2017-00147, 1226348-2017-00146, 1226348-2017-00145, 1226348-2017-00144, 1226348-2017-00143, and 1226348-2017-00142.

Event Description

In the literature article ¿analysis of closed-cell intracranial stent characteristics using cone-beam computed tomography with contrast material¿ by wataro tsuruta et all, published neurol med chir (tokyo) 53, 403-408, 2013, it was reported that in the time frame of 2012 ¿ 2013, there were 43 events associated with the implantation of 39 unknown enterprise stents, including inaccurate placement (10), inadequate radiopacity (10), migration (1), kink/bent (7), incomplete expansion (9) and damage to the vessels described as linearization post implantation (6).The article discussed a protocol to visualize nitinol stents.In the study, there were 39 aneurysms in 37 patients treated with stent-assisted coil embolization using enterprise stents.The aneurysms were located on the internal carotid artery in 24 cases, the anterior communicating artery (acoma) in three, the basilar artery (ba) in ten and the vertebral artery in two.Intraoperative 80kv high-resolution xperct was performed in all cases after deposition of the enterprise stent.They evaluated the coverage of the aneurysm neck, incomplete stent apposition (isa), and shift of vessels.Accurate stent visualization was achieved in 29 of 39 cases without coil or delivery wire artifact.Coverage of the aneurysm neck succeeded in 28 cases; there was one case of ba top y-configuration stenting in which the stent was dislocated into the aneurysm.Isa was detected in 9 cases, including seven kinks and on flattening in the carotid syphon and one kink in the ba top.They detected linearization of the vessels due to stent deployment in three acoma cases and three ba top cases.They concluded that intraoperative 80kv high-resolution xperct is an efficient modality for the evaluation of isa.No specific treatment information for any of the reported events was given.No patient specific information was given.No device specific information, i.E.Catalogue/lot number, was provided in the article.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• 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: 6849040
• MDR Text Key: 85153736
• Report Number: 1226348-2017-00142
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISEENC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1