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

Catalog Number UNKENTERPRISEENC

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # : (b)(4).Aneurysm recanalization, surgical intervention.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

Event description: this complaint is from a literature source.As reported in the literature publication entitled, ¿enlargement of asymptomatic va dissecting aneurysm" after initial treatment with stent-assisted coil embolization with contra lateral ruptured va dissecting aneurysm treated by parent artery occlusion: a case report¿.A (b)(6)-year-old male patient with a subarachnoid hemorrhage resulting from a bilateral vertebral artery dissecting aneurysms.The patient was treated within 24 hours of the hemorrhage to prevent re-rupture by parent artery occlusion of the right vertebral artery and stent-assisted coiling of the left side.A 6-month follow-up showed an enlargement of the left side dissecting aneurysm.A second treatment was done to the left side also using stent-assisted coiling.The patient was discharged with no neurological deficit.Enterprise stent used in the initial treatment and the lvis stent (arrows) used in the second operation.

• 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: 8875784
• MDR Text Key: 154022459
• Report Number: 1226348-2019-00971
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2019

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 Catalogue Number: UNKENTERPRISEENC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/08/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR