MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC UNKNOWN ENVOY 6F; PERCUTANEOUS CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Neurological Deficit/Dysfunction (1982); Occlusion (1984)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

Article attached to the mdr: qin f.; li z.; fang x.; et al.(2017).Therapeutic effect of enterprise stent-assisted embolization for very small ruptured intracranial aneurysms.Medicine, 96 (34), 2017.Article number: e7832.01 aug 2017.Date of event, product code, and lot number could not be obtained from the author.Udi: unknown part number, attempts to obtain product part number were unsuccessful, udi unavailable.Conclusion: the enterprise, envoy, and prowler select devices were not available for analysis.In addition, no lot numbers could be obtained; therefore, a dhr could not be performed for the devices.Emboli, vessel occlusion and neurological deficit is a known potential event that may be associated with the use of the enterprise vascular reconstruction device and delivery system or with the procedure and is listed in the instructions for use (ifu) as such.Based on the information provided in the article, the root cause of the events could not be determined; however, procedural and patient factors may have contributed to the event.During procedures, devices scrape the side of the vessel and can dislodge plaque that has form on the vessel walls.No additional information could be obtained from the author of the study.There is no current safety signal identified related to the reported events based on reviews of complaint histories for the devices.Since there was no evidence to suggest the event 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 3 mdr reports associated with this complaint with report numbers of 1226348-2017-00190, 3008264254-2017-00148.

Event Description

As reported in a literature article (qin f.; li z.; fang x.; zhao x.; liu j.; wu d.; lai n, ¿therapeutic effect of enterprise stent-assisted embolization for very small ruptured intracranial aneurysms¿ published by medicine (united states).96 (34) (no pagination), 2017.Article number: e7832.Date of publication: 01 aug 2017), a patient experienced occlusion of parent artery caused by plaque embolization following enterprise stent-assisted embolization with use of a 6f envoy guide catheter and prowler select plus microcatheter (catalog and lot numbers not provided in article) and non-codman coils.The (b)(6) female (patient 21) presented with a 2.7 x 21 mm middle cerebral artery aneurysm with a 2.4 mm aneurysm neck and hunt-hess 2.The patient had occlusion of distal middle cerebral artery caused by falling-off internal carotid artery plaque, which was not obviously improved after giving tirofiban for thrombolysis and had hemiplegia on one side.Patient clinical outcome was glasgow outcome scale (gos) 3.The retrospective study aimed to evaluate the safety and efficacy of enterprise stent-assisted coiling embolization of very small ruptured intracranial aneurysms.A total of 37 patients with ruptured very small intracranial aneurysms who had enterprise stent assisted coil embolization from february 2012 to july 2016 were included.All patients had clinical manifestations of spontaneous subarachnoid hemorrhage, which were confirmed by cranial ct.A select plus microcatheter was conducted through a microwire and positioned in the parent artery past the aneurysm neck.The enterprise stent was advanced through the select plus microcatheter and placed at the cephalic end of the microcatheter; however, the stent was not released.An echelon 10 microcatheter (ev3 endovascular, inc.) with a very small shaped tip was inserted into the aneurysmal sac or neck.Aneurysmal coiling was performed using an axium 3d coil (ev3 endovascular, inc.) of appropriate diameter and length.After 1 or 2 coil loops were released to fill the aneurysmal cavity, the stent was slowly released, and the release was stopped after the microcatheter was fixed and the coil did not pulsate.The aneurysmal cavity was continuously filled with the coil until 1¿2 cm of the coil remained inside the parent artery.The microcatheter was removed after the guidewire-achieved stability.After the position of the coil was stabilized, the stent was completely released and the coil was isolated.The article concluded that the enterprise stent-assisted coiling embolization can be a safe and effective technique for treatment of very small ruptured intracranial aneurysms.

• Brand Name: UNKNOWN ENVOY 6F
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: joaquin kurz ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 9497899383
• MDR Report Key: 7023260
• MDR Text Key: 91799022
• Report Number: 3008264254-2017-00149
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/21/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2017
• Initial Date FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR