MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EU ENT4.5MMD 22MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452200

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2019

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.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.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 is 1226348-2019-01021.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances related to the reported complaint condition were identified.

Event Description

As reported by a healthcare professional, during a percutaneous intracranial arterial stenting in the m2 segment of the right middle cerebral artery, the stent of a eu ent4.5mmd 22mml wno dstl tp (enc452200, 11160232) couldn't deploy.When the stent and the 150/5cm prowler select plus microcatheter (606s255x, 30225660) arrived at the target position and exceeded 7mm to deploy the stent, it failed.Then the stent and micro catheter (mc) were withdrawn together.The cerebral target position was lost.There was no patient injury reported.The procedure was completed with another new stent and catheter.

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 percutaneous intracranial arterial stenting in the m2 segment of the right middle cerebral artery, the stent of a eu ent4.5mmd 22mml wno dstl tp (enc452200, 11160232) couldn¿t deploy.When the stent and the 150/5cm prowler select plus microcatheter (606s255x, 30225660) arrived at the target position and exceeded 7mm to deploy the stent, it failed.Then the stent and micro catheter (mc) were withdrawn together.The cerebral target position was lost.There was no patient injury reported.The procedure was completed with another new stent and catheter.No additional information is available.One non-sterile unit eu ent4.5mmd 22mml wno dstl tp was received inside of a pouch.The received device was visually inspected, and no damages were noticed.A prowler select plus 150/5cm microcatheter was received and was flushed using a lab sample syringe.After that, the unit eu ent4.5mmd 22mml wno dstl tp was introduced into the received prowler select and it advance, a slightly resistance/friction was felt.The unit eu ent4.5mmd 22mml wno dstl tp can pass through the received microcatheter.The complaint reported by the customer ¿stent- deployment difficulty-partial deployment¿ was not able to be confirmed.The unit was able to can pass through the received microcatheter and it was able to deploy without difficulty.The complaint reported by the customer ¿delivery wire - withdrawal difficulty-unable to¿ was not able to be confirmed.The unit passed through the same microcatheter, then the stent and microcatheter were withdrawn together.However, a slightly resistance/friction was felt on the functional test.Neither the analysis nor the mre suggest that the failure reported could be related to the manufacturing process.Deployment difficulty is a known potential product failure associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Of note, the device was being used off-label to treat carotid artery stenosis.According to the instructions for use (ifu), the enterprise stent is intended for use with occlusive devices in the treatment of intracranial aneurysms and is not intended as a stand-alone device.Assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided.However, it is possible that clinical and procedural factors, including device manipulation and vessel characteristics, may have contributed to the reported failures.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: EU ENT4.5MMD 22MML 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: 9320947
• MDR Text Key: 216653074
• Report Number: 1226348-2019-01022
• 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
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Catalogue Number: ENC452200
• Device Lot Number: 11160232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM