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 Infarction, Cerebral (1771)

Event Date 01/31/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Contact office: codman and shurtleff, inc (b)(4).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, ¿spinal cord infarction in the region of the posterior spinal artery after embolization for vertebral artery dissection.¿ a (b)(6) year-old female patient with a fusiform aneurysm in the left vertebral artery (va), distal to the posterior inferior cerebellar artery (pica) (post-pica type) who underwent stent assisted coil embolization experienced periprocedural symptomatic infarction.The ischemic lesion was located in the region of the posterior spinal artery (psa).The patient¿s symptoms improved, and she was discharged without her having any significant disability.Objective: to investigate psa infarction after endovascular surgery for vad.Methods: infarction in the region of the psa after endovascular surgery for vads carried out in consecutive 21 cases was investigated from 2007 through 2015.The variables of aneurysmal location, status, intra-aneurysmal thrombosis, antithrombotic therapy, and endovascular procedure were investigated in relation to the occurrence of spinal cord or brain stem infarction.

• 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): SEE H10; circuito interior norte #1820; juarez chihuahua ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8814054
• MDR Text Key: 151848672
• Report Number: 1226348-2019-00958
• 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: 07/01/2019

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: 07/01/2019
• Initial Date FDA Received: 07/22/2019
• 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): Life Threatening
• Patient Age: 56 YR