MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EU ENT4.5MMD 28MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452800

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer information was not provided; however, the event occurred at (b)(6) hosp.In (b)(6).The customer information provided in this mdr is the (b)(6) affiliate.It was reported that the device would be returned for analysis; however, the device was not returned.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during the procedure, the enterprise stent (enc452800/ 10882825) could not be advanced via an unspecified microcatheter.They withdrew the stent with the microcatheter and used another stent to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was received on 12/20/2017: the procedure was stent assisted embolization of an intracranial aneurysm.The microcatheter used was unknown; however, there were not kinks in the microcatheter and a continuous flush had been maintained.There was no clinically significant delay in the procedure and when the stent was removed the stent was still on the delivery wire.The patient age, gender, weight and medical history could not be obtained.The microcatheter was available to be returned for analysis.The customer information was: (b)(6).Product returned 1/2/2018.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by a healthcare professional, during stent assisted embolization of an intracranial aneurysm, the enterprise stent (enc452800/ 10882825) could not be advanced via an unspecified microcatheter.They withdrew the stent with the microcatheter and used another stent to complete the procedure.A continuous flush had been maintained through the microcatheter and there were no kinks in the microcatheter.There were no clinically significant delays in the procedure and when the stent was removed the stent was still on the delivery wire.Patient age, gender, weight and medical history could not be obtained.There was no report of patient injury.A non-sterile enterprise device was received inside of a plastic bag.The delivery wire and the introducer tube were inspected and no damages were noted; however, the stent was found deployed.The stent was inspected under microscope and no damages were noted on it.The functional analysis could not be performed since the stent was received deployed and it is necessary that the stent is still inside of the introducer tube to perform the functional analysis.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of the lot 10882825.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The resistance between the enterprise and the microcatheter could not be evaluated or confirmed since the stent was received deployed.The device did not present any obvious indication of manufacturing defect or anomaly that could contributed to the event as reported.Neither the product analysis nor the dhr review suggests that the failure could be related to the enterprise manufacturing process.Procedural factors and handling process may contribute to the failure as reported.There is no current safety signal identified related to the reported event based on review of complaint history for the device.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 28MML WNO DSTL TP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: joaquin kurz ; 325 paramount dr; raynham, MA 02767 ; 650687-492
• MDR Report Key: 7133542
• MDR Text Key: 95935704
• Report Number: 1226348-2017-00510
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704071488
• UDI-Public: (01)10886704071488(17)19/07/28(10)10882825
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Catalogue Number: ENC452800
• Device Lot Number: 10882825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1