MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EU ENT4.5MMD 37MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC453700

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.The product is available for evaluation and testing; however, it has not been received to date.This is one of two products involved with the complaint and the associated manufacturer report numbers are (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by a healthcare professional, during an intracranial stent assist coil embolization, a 4.5mmd 37mml enterprise stent (enc453700, 11106417) became stuck in y connector through withdrawn.The stent was deployed partly when it arrived the target position.But the physician thought the position was not good enough.The user then advanced the prowler select plus micro catheter (mc) to pull back the stent.The stent got back into the micro catheter successfully.Afterwards, the physician was going to pull back the stent, adjust the microcatheter to another position, and put the stent into microcatheter again.However, the stent became stuck in the y connector of the microcatheter.The physician withdrew it a little bit heavily and the delivery wire became separated with the stent.The stent was still stuck in the catheter.Physician had to withdraw the microcatheter with the stent together and replaced by a new stent and microcatheter (same product code) to complete the operation.No patient injured reported.Target position was lost.

Manufacturer Narrative

Product complaint (b)(4).Additional information received confirmed that the stent prematurely deployed in the microcatheter hub.No excessive force was applied at any time.It was verified that the introducer was fully seated & secured in the hub.Adequate continuous flush was maintained through the catheter.Another similar device went through the same microcatheter without difficulty.The rhv was not opened to allow the passage of the device.The stent/stent delivery system did not appear damaged.The rhv/mc did not appear damaged.The mc or the stent delivery did not kink or bend at any time.There was no patient injury.There were no procedural delays due to the event.The same rhv/mc was not used to complete the procedure.The devices were used as per the instructions for use (ifu).The stent was still attached to the delivery wire when removed from the patient.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 an intracranial stent assist coil embolization, a 4.5mmd 37mml enterprise stent (enc453700, 11106417) became stuck in y connector through withdrawn.The stent was deployed partly when it arrived the target position.But the physician thought the position was not good enough.The user then advanced the prowler select plus microcatheter (product/lot unknown) to pull back the stent.The stent got back into the micro catheter successfully.Afterwards, the physician was going to pull back the stent, adjust the microcatheter to another position, and put the stent into microcatheter again.However, the stent became stuck in the y connector of the microcatheter.The physician withdrew it a little bit heavily and the delivery wire became separated with the stent.The stent was still stuck in the catheter.Physician had to withdraw the microcatheter with the stent together and replaced by a new stent and microcatheter (same product code) to complete the operation.No patient injured reported.Target position was lost.Additional information received confirmed that the stent prematurely deployed in the microcatheter hub.No excessive force was applied at any time.It was verified that the introducer was fully seated & secured in the hub.Adequate continuous flush was maintained through the catheter.Another similar device went through the same microcatheter without difficulty.The rhv was not opened to allow the passage of the device.The stent/stent delivery system did not appear damaged.The rhv/mc did not appear damaged.The mc or the stent delivery did not kink or bend at any time.There was no patient injury.There were no procedural delays due to the event.The same rhv/mc was not used to complete the procedure.The devices were used as per the instructions for use (ifu).The stent was still attached to the delivery wire when removed from the patient.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11106417.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.With the information available and without the product available for analysis, the reported customer complaint of ¿delivery wire - impeded in microcatheter with loss of cerebral target position¿ 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.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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 ENT4.5MMD 37MML WNO DSTL TP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8975797
• MDR Text Key: 204602557
• Report Number: 1226348-2019-00980
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Catalogue Number: ENC453700
• Device Lot Number: 11106417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKPROWLERSELECT