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

Catalog Number ENC452212

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2019-01031.

Event Description

As reported by a healthcare professional, during a is stent-assisted aneurysm embolization, the stent of a 4.5x22mm enterprise stent delivery system 12 mm dw tip (enc452212, 10989445) could not move in a prowler select plus 150/5cm microcatheter (606s255x, 30220160).Then physician withdrew the sent and microcatheter (mc) outside of body together.During checking, the stent deployed outside of the body, the body of the microcatheter was found wrinkle (creased).The cerebral target position was lost because the stent and mc was replaced by a new same code device.The procedure was completed by the new stent and mc.There was no patient injury reported.No additional intervention was needed to remove the devices from the patient.Adequate flush was maintained through the devices.No additional information is available.

Manufacturer Narrative

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, during a is stent-assisted aneurysm embolization, the stent of a 4.5x22mm enterprise stent delivery system 12 mm dw tip (enc452212, 10989445) could not move in a prowler select plus 150/5cm microcatheter (606s255x, 30220160).Then the physician withdrew the stent and microcatheter (mc) outside of the body together.During checking, the stent deployed outside of the body, the body of the microcatheter was found wrinkle (creased).The cerebral target position was lost because the stent and mc were replaced by a new same code devices.The procedure was completed by the new stent and mc.There was no patient injury reported.No additional intervention was needed to remove the devices from the patient.Adequate flush was maintained through the devices.No additional information is available.One non-sterile unit eu 4.5x22mm stent 12 mm dw tip was received inside of a pouch.The received device was visually inspected, the introducer was found separated from the unit, the stent was not returned for evaluation.No other damages were observed.The functional analysis could not be performed due to the introducer was returned separated from the unit and the stent was not returned for evaluation.It is necessary that the stent is still inside of the introducer tube to perform the functional analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 10989445.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint reported by the customer ¿delivery wire - impeded in microcatheter with loss of cerebral target position¿ was not able to be confirmed.The functional analysis could not be performed, as it is necessary that the stent is still inside of the introducer tube to perform the functional analysis.Per the event description, the stent was deployed outside of the patient¿s body.The instructions for use (ifu), warns to not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device.However, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• 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: 9457705
• MDR Text Key: 204248096
• Report Number: 1226348-2019-01030
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Catalogue Number: ENC452212
• Device Lot Number: 10989445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM