MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452212

Device Problem Retraction Problem (1536)

Patient Problem No Code Available (3191)

Event Date 03/24/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, race, and ethnicity were not provided.(b)(4).Withdrawal difficulty and emergent neurosurgery are known potential complications associated with the use of the enterprise stent and in stent-assisted coil embolization procedures.The introduction and withdrawal procedure of the enterprise vrd is technique-driven, requiring proper orientation and positioning of each component of the system.The root cause of the event could not be conclusively determined based on the minimal information available for review; however, it appears that procedural factors may have contributed to the event.Since the withdrawal difficulty required surgical intervention (i.E.Open craniotomy) to remove the system from the patient and to treat the aneurysm, the event meets mdr reporting criteria as a ¿serious injury¿.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 procedure targeting an internal carotid artery aneurysm, repeated unsuccessful attempts were made to remove the delivery wire of the 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212 / 10998142) to release the stent resulted in a craniotomy procedure to surgically remove the stent and to clip the aneurysm.It was reported that the stent was still on the delivery wire when it was removed from the patient.There was no report of patient complications as a result of the event, but the endovascular repair procedure was delayed for approximately two hours as the procedure was changed from a stent-assisted coil embolization procedure to an open craniotomy procedure.It was reported that the delivery wire could not be separated from the stent.¿after the stent was released, the physician pushed the prowler select plus microcatheter (catalog/lot# unknown) along the delivery wire to the distal end and found that it could not move, and then withdrew the delivery wire and found that the wire could not be separated from the stent¿.It was reported that the device is not available to be returned for evaluation and analysis.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to document the result of the analysis of the production records for lot 10998142.[conclusion]: the healthcare professional reported that during the stent-assisted coil embolization procedure targeting an internal carotid artery aneurysm, repeated unsuccessful attempts were made to remove the delivery wire of the 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212 / 10998142) to release the stent resulted in a craniotomy procedure to surgically remove the stent and to clip the aneurysm.It was reported that the stent was still on the delivery wire when it was removed from the patient.There was no report of patient complications as a result of the event, but the endovascular repair procedure was delayed for approximately two hours as the procedure was changed from a stent-assisted coil embolization procedure to an open craniotomy procedure.It was reported that the delivery wire could not be separated from the stent.¿after the stent was released, the physician pushed the prowler select plus microcatheter (catalog/lot# unknown) along the delivery wire to the distal end and found that it could not move, and then withdrew the delivery wire and found that the wire could not be separated from the stent.¿ it was reported that the device is not available to be returned for evaluation and analysis.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (10998142) presented no issues during the manufacturing or inspection processes related to the reported complaint.The device history records indicate that this product underwent final inspection testing at lake region medical and was determined to be acceptable.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Withdrawal difficulty and emergent neurosurgery are known potential complications associated with the use of the enterprise stent and in stent-assisted coil embolization procedures.The introduction and withdrawal procedure of the enterprise vrd is technique-driven, requiring proper orientation and positioning of each component of the system.The root cause of the event could not be conclusively determined based on the minimal information available for review; however, it appears that procedural factors may have contributed to the event.Since the withdrawal difficulty required surgical intervention (i.E.Open craniotomy) to remove the system from the patient and to treat the aneurysm, the event meets mdr reporting criteria as a ¿serious injury.¿ with the information documented in the complaint but without the product and concomitant microcatheter available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that procedural factors may have contributed to the reported event.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: EU 4.5X22MM STENT 12 MM DW TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8538208
• MDR Text Key: 142737047
• Report Number: 1226348-2019-00879
• 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: 03/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Catalogue Number: ENC452212
• Device Lot Number: 10998142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 59