MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC STENT - VASCULAR RECONSTRUCTION; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISEENF

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

Patient Problems Paralysis (1997); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(6) hospital for neuroscience.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.  device history record (dhr) review cannot be conducted because the no lot number was provided by the customer. .

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿case report of de novo cavernous carotid artery aneurysm after an acute stroke intervention for a carotid occlusion¿.A (b)(6) female patient with a left internal carotid artery (ica) just distal to the bifurcation who underwent mechanical thrombectomy with solitaire device, penumbra suction and enterprise stent placement (codman, (b)(6)) developed complete ptosis of the left eye with minimally reactive pupil and a third nerve palsy in four weeks after the left ica stent placement.A computed tomography angiogram showing an 8- mm aneurysm of the left cavernous ica.A cerebral angiogram was performed showing a 10- 7-mm cavernous pseudoaneurysm.The decision was made to treat the aneurysm with pipeline-assisted coiling.The procedure went well without any complications.A 6-week clinical follow up showed that the third nerve palsy had completely resolved.The aim of this study to present the first case of arterial dissection complicated by an occlusion and a pseudoaneurysm occurring at the same site.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8756096
• MDR Text Key: 149927036
• Report Number: 1226348-2019-00921
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISEENF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR