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

Catalog Number ENC402300

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Concomitant medical products: sheath introducer (6fterumo),guide wire (chikai14, asahi intec., guiding catheter (slim guide, medikit), y connector (goodtec).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 1226348-2017-00005 and 3008264254-2017-00010.

Event Description

As reported by a healthcare professional, during stent assisted coil embolization of a left vertebral artery aneurysm, a prowler select plus (606-s255x, 17541950) slid from the aneurysm and the enterprise 2 (enc402300, 10619452) could not be recaptured.They had attempted to deploy the enterprise 2 when the prowler select plus slid.Therefore they attempted to recapture the enterprise 2 in the microcatheter, but distal maker part of the enterprise 2 became stuck at tip of the micro catheter.The physician attempted deployments and storage repeatedly, but the issue was not improved.Therefore, the system was removed as a unit from patient¿s body and the enterprise 2 and prowler select plus were replaced.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 unintended detachment was observed in the vessel or in the microcatheter.The patient¿s vessel was moderately tortuous and no calcified.The products were returned for investigation.No further information was available.

Manufacturer Narrative

Conclusion: as reported by a healthcare professional, during stent assisted coil embolization of a left vertebral artery aneurysm, a prowler select plus (606-s255x, 17541950) slid from the aneurysm and the enterprise 2 (enc402300, 10619452) could not be recaptured.They had attempted to deploy the enterprise 2 when the prowler select plus slid.Therefore they attempted to recapture the enterprise 2 in the microcatheter, but distal maker part of the enterprise 2 became stuck at tip of the microcatheter.The physician attempted deployments and storage repeatedly, but the issue was not improved.Therefore, the system was removed as a unit from patient¿s body and the enterprise 2 and prowler select plus were replaced.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 unintended detachment was observed in the vessel or in the microcatheter.The patient¿s vessel was moderately tortuous and no calcified.The products are not available for investigation.No further information was available.A non-sterile enterprise device was received inside of a plastic bag.The delivery wire was received inside of the microcatheter.The delivery wire was removed of the microcatheter without any difficulty and no damages were noted on it.The introducer tube was not returned for evaluation.The stent was received deployed and no damages were noted on it.The delivery wire and stent were inspected under vision system and no anomalies were noted on them.The functional analysis could not be performed since the stent was received deployed, introducer tube was not returned and it is necessary that the stent is still inside of the introducer tube to perform the functional analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of this complaint involved lot # 10619452.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 reported by the costumer as ¿stent- inability to recapture¿ could not confirmed or evaluated 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.Handling and procedural factors could be contributed to this condition.No corrective action will be taken at this time.This is 1 of 2 mdrs being submitted for this complaint with associated report numbers of 1226348-2017-00005 and 3008264254-2017-00010.

• 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: 6294034
• MDR Text Key: 66277275
• Report Number: 1226348-2017-00005
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075202
• UDI-Public: (01)10886704075202(17)181031(10)10619452
• 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: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: ENC402300
• Device Lot Number: 10619452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1