MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC453712

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

Prowler select plus microcatheter (606s255x/17293464).(b)(4).It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of the above mentioned lot.The device history record review also included a review of the certificate of conformance received from specialty coatings systems and nitinol devices and components, along with lake region medical¿s internal receiving inspection records for the stents issued to the complaint lot.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdr reports being submitted for this complaint, with associated report numbers of 3008264254-2016-00087 and 1226348-2016-00183.

Event Description

As reported by a healthcare professional, during the stent assisted coil embolization of the posterior communicating artery aneurysm, the enterprise stent (enc453712/ 10602078) could not be advanced via the prowler select plus microcatheter (606s255x/ 17293464).They withdrew the coil with microcatheter and used new products to complete the procedure.There had been a continuous flush through the microcatheter.Neither the prowler nor the enterprise appeared damaged after removal.The devices had been prepped and used as per the instructions for use (ifu).There was no report of patient injury or significant delay in the procedure.It was reported that the products would be returned for analysis.

Manufacturer Narrative

The device was returned for analysis on 12/15/2016.Conclusion: as reported by a healthcare professional, during the stent assisted coil embolization of the posterior communicating artery aneurysm, the enterprise stent (enc453712/ 10602078) could not be advanced via the prowler select plus microcatheter (606s255x/ 17293464).They withdrew the coil with microcatheter and used new products to complete the procedure.There had been a continuous flush through the microcatheter.Neither the prowler nor the enterprise appeared damaged after removal.The devices had been prepped and used as per the instructions for use (ifu).There was no report of patient injury or significant delay in the procedure.It was reported that the products would be returned for analysis.A non-sterile enterprise device was received inside of a plastic bag.The delivery wire was inspected and it was found without any damage.The introducer tube was received separated of the delivery wire and no damages were noted on it.The functional analysis could not be performed through the microcatheter received 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.(b)(4)reviewed the device history records relative to the manufacturing, inspecting and packaging of this complaint involved lot # 10602078.The device history record review also included a review of the certificate of conformance received from specialty coatings systems and nitinol devices and components, along with (b)(4) internal receiving inspection records for the stents issued to the complaint lot.The history records indicate this product was final inspection tested at (b)(4) and was determined to be acceptable.The enterprise resistance within the microcatheter could not be confirmed since the event could not be evaluated due to the stent being 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.No corrective action will be taken at this time.This is 1 of 2 mdr reports being submitted for this complaint, with associated report numbers of 3008264254-2016-00087 and 1226348-2016-00183.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; 325 paramount dr; raynham, MA 02767 ; 5088288374
• MDR Report Key: 6151221
• MDR Text Key: 61872417
• Report Number: 1226348-2016-00183
• Device Sequence Number: 1
• Product Code: NJE
• 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
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Catalogue Number: ENC453712
• Device Lot Number: 10602078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR