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 Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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.    this is one of two products involved with the reported complaint and the associated manufacturer report numbers are 1226348-2019-00970.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿ bilateral vertebral artery dissecting aneurysms presenting with subarachnoid hemorrhage treated by staged coil trapping and covered stents graft¬¿ a (b)(6)-year-old woman with subarachnoid hemorrhage (sah) and bilateral vertebral artery dissecting aneurysms (vadas) the right vada was considered ruptured because the sah predominated on the right side and the right vada was larger than the contralateral vada.Endovascular coil trapping of the ruptured right vada was performed on the same day using 19 coils.One month later, two overlapping stents (sws) implantation (enterprise 4.5×22 mm, and 4.5×28 mm, cordis neurovascular, miami, fl, usa) was performed for the unruptured left vada to prevent possible growth due to increased hemodynamic stress to the left va caused by contralateral va sacrifice.After double stent implantation for the left vada, blood flow to aneurysmal sac was slightly reduced.Eight months follow-up angiograms demonstrated stable occlusion of the right vada and marked growth of the left vada.Left vada was re-treated with further coil packing into the growing pseudosacs and bailout stenting using a 4.5×28 mm enterprise stent to maintain left va flow postoperative angiograms showed near complete obliteration of the vada, and sparing of left pica flow.However, follow-up angio¬grams 4 months later showed regrowth of the left vada.The authors report a rare case of bilateral vadas presenting with sah, which was treated with internal trapping of the ruptured dissecting segment and covered stent graft after sws and subsequent multiple session of sac of the contralateral unruptured vada.

Manufacturer Narrative

This is a correction of the previous submission report related to the literature article entitled ¿bilateral vertebral artery dissecting aneurysms presenting with subarachnoid hemorrhage treated by staged coil trapping and covered stents graft".The product code was updated from unkenterpriseenc to unkenterpriseenf.

• 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: 8872013
• MDR Text Key: 153959401
• Report Number: 1226348-2019-00969
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• 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: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 44 YR