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

Catalog Number ENC452212

Device Problems Difficult or Delayed Positioning (1157); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The prowler select plus microcatheter was not returned for analysis.Review of dhr for lot 17409255 that 1 rejected unit (due to tight id) may be related to the reported complaint.However, the dhr review confirmed that the rejected unit was properly segregated and discarded.Controls are in place to detect such nonconformities.No other issues were noted that were considered potentially related to the reported complaint.The enterprise (lot 10507216) was not returned for analysis.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.The failure of the enterprise stents to be deployed through the prowler select plus microcatheter could not be confirmed without product return for analysis.The root cause of the event could not be determined based on the information provided.Device handling/procedural factors may have contributed to the event.There was no evidence of a manufacturing issue related to the event; therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.This is 1 of 4 mdr reports being submitted for this complaint, with associated report numbers of 3008264254-2017-00037, 1226348-2017-00046, 1226348-2017-00047 and 3008264254-2017-00038.

Event Description

The contact from the facility reported that the enterprise stent (enc452212/10507216) could not be deployed through the prowler select plus microcatheter (606s255x/17409255.) the patient had a left internal carotid ophthalmic aneurysm.The physician withdrew the stent with the microcatheter after it could not be deployed.The physician used new enterprise stent (enc452212/10507216) and microcatheter (606s255x/ 17409255), but the stent did not deploy.The stent was exchanged with the microcatheter again to complete the procedure.Nothing unusual was noted with the system prior to use, and a continuous flush had been maintained through the catheter.It was verified that the introducer was fully seated and secured in the microcatheter hub.There were no kinks noted on the catheter, and the catheter had not been re-shaped.The catheter was placed distal to the target site prior to advancement of the device to the target site followed by withdrawal of the catheter to deploy the device.There was no report on the patient injury and no significant delay in the procedure.The devices were discarded by the customer.

• 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: 6435980
• MDR Text Key: 71104134
• Report Number: 1226348-2017-00047
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704043980
• UDI-Public: (01)10886704043980(17)170228(10)10507216
• 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
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: ENC452212
• Device Lot Number: 10507216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS (606S255X/17409255)
• Patient Age: 55 YR