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

Catalog Number ENC401600

Device Problems Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdrs being submitted for this complaint with associated report numbers of 1226348-2017-00023 and 3008264254-2017-00033.

Event Description

As reported by a healthcare professional, during coil embolization of an internal carotid-posterior communicating artery aneurysm, it was reported that there was resistance between the enterprise 2 (enc401600/10554706) and the prowler select plus (catalog/lot unknown), and both devices were removed from the patient.They had originally planned to deploy with a 16 mm, but the enterprise position migrated, so the physician tried to retrieve the device.At the time, positioning maker limit was not exceeded.However, the marker could not be placed into the microcatheter.The physician commented that the marker could not be placed into the microcatheter because there was heavy tortuosity at the placement site.Therefore, the enterprise 2 was removed from the body with the microcatheter as unit.When it came out from the catheter, the enterprise deployed (outside the patient¿s body).The enterprise was replaced with another one (23mm).The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported and no reported delay in the procedure.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to (and after) the event.No further information was available.

Manufacturer Narrative

Conclusion: as reported by a healthcare professional, during coil embolization of an internal carotid-posterior communicating artery aneurysm, it was reported that there was resistance between the enterprise 2 (enc401600/10554706) and the prowler select plus (catalog/lot unknown), and both devices were removed from the patient.They had originally planned to deploy with a 16 mm, but the enterprise position migrated, so the physician tried to retrieve the device.At the time, positioning maker limit was not exceeded.However, the marker could not be placed into the microcatheter.The physician commented that the marker could not be placed into the microcatheter because there was heavy tortuosity at the placement site.Therefore, the enterprise 2 was removed from the body with the microcatheter as unit.When it came out from the guiding catheter, enterprise deployed (outside the patient¿s body).The enterprise was replaced with another one (23 mm).The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to or after the event.No further information was available.A non-sterile enterprise device was received inside of a plastic bag.The delivery wire was inspected and no damages were noted on it.The introducer tube was found separated of the devices as well as 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 10554706.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 prowler select plus was not returned for analysis.In addition, the lot number was not provided; therefore, a dhr review could not be performed.The enterprise withdrawal difficulty through the prowler select plus could not be evaluated or confirmed since the stent was deployed.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 reported.No corrective actions will be taken at this time.This is 1 of 2 mdrs being submitted for this complaint with associated report numbers of 1226348-2017-00023 and 3008264254-2017-00033.Correction: product returned on 03/07/2017.

• 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: 6406048
• MDR Text Key: 70081744
• Report Number: 1226348-2017-00023
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075189
• UDI-Public: (01)10886704075189(17)180528(10)10554706
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Catalogue Number: ENC401600
• Device Lot Number: 10554706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS (CATALOG/LOT UNKNOWN)
• Patient Age: 62 YR