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 Problems No Patient Involvement (2645); No Code Available (3191)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Aneurysm rupture.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.  missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.  information regarding patient weight, height, medical history, race, and ethnicity was not reported.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿single-center case series of temporary stent assistance for coiling of acutely ruptured aneurysms¿ (pmid:30579035).A patient with a wide-necked intracranial (posterior communicating artery) unruptured aneurysm who underwent temporary stent-assisted coil embolization with a stent - enterprise experienced an intraoperative aneurysm rupture.The study describes temporary stent assistance using retrievable stents for the coiling of ruptured intracranial aneurysms as an endovascular management option.Methods: surgeon case logs were retrospectively reviewed for cases of temporary stent assistance for aneurysm coiling.Cases were identified and compiled into a case series.

Manufacturer Narrative

This is a correction of the previous submission related to the literature article entitled ¿single-center case series of temporary stent assistance for coiling of acutely ruptured aneurysms.¿ the article was rereviewed, as originally mentioned in the article the stent enterprise was used for temporary stent assistance.The stent was partially deployed and used to assist with coiling but was recaptured before detachment owing to the intraoperative rupture of the aneurysm.During deployment of the first coil, the coil could not maintain its shape at the neck of the aneurysm; therefore, the stent was partially deployed.During placement of the third coil into the aneurysm, coil loops were noted to extrude into the subarachnoid space.An ica injection demonstrated contrast extravasation.Based on the provided information the enterprise stent was not involved in the mentioned event and should be dedicated as a concomitant device.Therefore the event does not meet mdr reporting criteria and was no need to be reported as mdr.Patient code has been updated to no adverse event.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9403198
• MDR Text Key: 168870977
• Report Number: 1226348-2019-01028
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• 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
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other