MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC402312

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant med products: prowler select plus 150/5cm microcatheter.This is one of 2 products involved with the reported complaint and the associated manufacturer report numbers are 1226348-2018-00612 and 008264254-2018-00527.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during the stent-assisted coil embolization of a right paraclinoid internal carotid artery (ica) aneurysm that is 6 mm x 10 mm with the neck size of 5.24 mm, the prowler select plus 150/5cm was advanced into the middle cerebral artery and the enterprise1 4 mm x 23 mm stent (enc402312 / 10566079) was inserted into the microcatheter where it became stuck at about 15 cm from the proximal portion of the microcatheter.The enterprise2 stent and the prowler select plus microcatheter were removed and replaced.The procedure was successfully completed without further issues or delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.The enterprise2 stent is not available to be returned for analysis.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during the stent-assisted coil embolization of a right paraclinoid internal carotid artery (ica) aneurysm that is 6 mm x 10 mm with the neck size of 5.24 mm, the prowler select plus 150/5cm was advanced into the middle cerebral artery and the enterprise1 4 mm x 23 mm stent (enc402312 / 10566079) was inserted into the microcatheter where it became stuck at about 15 cm from the proximal portion of the microcatheter.The enterprise2 stent and the prowler select plus microcatheter were removed and replaced.The procedure was successfully completed without further issues or delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.The enterprise2 stent is not available to be returned for analysis.Investigation summary: based on complaint information, the device was not available to be returned for analysis.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of causes and possible contributing factors could be made.As such the investigation will be closed.Device history lot: lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 10566079.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: ENTERPRISE2 4MMX23MM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 7630262
• MDR Text Key: 112576871
• Report Number: 1226348-2018-00612
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Catalogue Number: ENC402312
• Device Lot Number: 10566079
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1