MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX16MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR401600

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

Patient Problem Restenosis (4576)

Event Date 07/05/2022

Event Type  Injury  

Event Description

As reported via the empower study, a 58-year-old female (b)(6) with a history of hypertension and allergic asthma underwent stent-assisted coil embolization of an unruptured middle cerebral artery (mca) aneurysm on (b)(6) 2021.On (b)(6) 2022, the patient experienced stent stenosis, which is still ongoing.The principal investigator assessed the event as mild in severity and as intra-stent stenosis.The relationship between the study device and the procedure was not entered into the crf.The event has not been resolved and the patient has not recovered.No further information was provided.The saccular aneurysm had the following dimensions: maximum aneurysm diameter of 3.5mm and neck width of 3.3mm.The parent vessel diameter was 3.0mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4mm x 16mm enterprise 2 vascular reconstruction device (vrd) (encr401600/5964701) and unspecified coils.There were no reported intraoperative complications or study device deficiencies.The immediate post-procedure assessment showed raymond-roy's score of class i: complete obliteration.A routine neurological examination performed prior to discharge on (b)(6) 2021 revealed a hunt & hess grade 0 and a modified rankin scale (mrs) score of 0.30-day follow-up visit was performed via phone on (b)(6) 2021.Digital subtraction angiography (dsa) is planned for 180 days after the study procedure.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, race, and ethnicity was not reported.Patient identifier: (b)(6).The device remains implanted, therefore, no further investigation can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 5964701.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #(b)(4).Additional information was received on 22-jul-2022.A summary of the additional information provided indicated that it was reconfirmed by the principal investigator, that the patient did not experience in-stent restenosis.No more information could be obtained at this time.Therefore the event is being unreported.

• Brand Name: ENTERPRISE2 4MMX16MM NO TIP
• 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 02767
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15054410
• MDR Text Key: 296159104
• Report Number: 1226348-2022-00002
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

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 Expiration Date: 08/28/2023
• Device Catalogue Number: ENCR401600
• Device Lot Number: 5964701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR
• Patient Sex: Female