MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC402300

Device Problems Off-Label Use (1494); Product Quality Problem (1506); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient age/date of birth, gender, weight, height, relevant medical history, race, and ethnicity was not reported.The product is not available for evaluation and testing; however, we will review the manufacturing and quality records as applicable per our internal procedure.These records will comprise our lots/batches history records, which were created during the manufacturing of the device.Additional information will be submitted within 30 days of receipt.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2019-00856 & 1226348-2019-00857.

Event Description

As reported by a healthcare professional, when the physician advanced the 4mm x 16mm enterprise 2 (enc401600/10715556) through the prowler select plus 15cm (606s252fx/17772892) microcatheter, he was only able to visualize the delivery wire under fluoroscopy.The stent did not appear under fluoro outside of the microcatheter.A 4mm x 23mm enterprise 2 was selected (enc402300/11020343), but the same issue occurred.Therefore, the device was replaced with a 4mm x 39mm enterprise 2 (enc403900/11001897), and the physician was able to see the ¿fleared ends¿, but it was not possible to advance the device out of the prowler select plus microcatheter.There was no report of consequence or impact to the patient.The devices will not be returned for evaluation.No further information was provided.

Manufacturer Narrative

Product complaint (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2019-00857.

Manufacturer Narrative

Product complaint(b)(4).Section b5: additional information received indicated that the intended procedure was off-label stenting of a distal right carotid artery occlusion/stenosis with calcification in a patient presenting with an acute ischemic stroke.The reported issue was not inadequate radiopacity, but that the stents could not be deployed from the microcatheter.When the physician retracted the microcatheter to deploy the first enterprise 2 stent (enc401600/10715556), he was only able to visualize the tip of the delivery wire on fluoroscopy.Therefore, the physician removed the enterprise 2 from the prowler select plus microcatheter.The stent was still on the delivery wire upon removal from the patient.The enterprise 2 was replaced with a 4mm x 23mm enterprise 2 (enc402300/11020343), but the same issue occurred.The stent would not exit the distal tip of the microcatheter.Therefore, the enterprise 2 was removed from the microcatheter.The stent was still on the delivery wire upon removal.The enterprise 2 was replaced with a 4mm x 39mm enterprise 2 (enc403900/11001897), but the physician was only able to see the ¿flared ends¿ of the stent.The stent would not exit the distal tip of the microcatheter.During withdrawal, the stent prematurely deployed in the hub of the microcatheter.The system was removed from the patient due to ¿safety reasons¿ and the physician decided to resort to percutaneous transluminal angioplasty (pta) without stenting.The procedure was delayed one hour due to the events, but it is not clear if the procedural delay was considered clinically significant.There was no report of patient injury and the patient¿s baseline condition did not worsen as a result of the events.Additional intervention was not required.There was no difficulty withdrawing the enterprise stents from the microcatheter.It was reported that an adequate and continuous flush was maintained through the microcatheter.The microcatheter did not appear damaged in any way and the same microcatheter was used to complete the procedure.The user had not applied undue force when handling the devices.The devices will be returned for evaluation.Based on the additional information provided, this complaint no longer meets the criteria for medical device reporting because the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.In addition, the enterprise stent was being used off-label.The enterprise stent is intended for use with occlusive devices in the treatment of intracranial aneurysms and is not intended as a stand-alone device.The product is available for evaluation and testing; however, it has not been received to date (which is indicated as "other" in section h3).Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11001897.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2019-00857.

Manufacturer Narrative

Product complaint (b)(4).As reported by a healthcare professional, during an off-label stenting of a distal right carotid artery occlusion/stenosis with calcification in a patient presenting with an acute ischemic stroke, the 4mm x 16mm enterprise 2 (enc401600/10715556), the 4mm x 23mm enterprise 2 (enc402300/11020343), and the 4mm x 39mm enterprise 2 (enc403900/11001897) could not be deployed from the prowler select plus 15cm 45tip (606s252fx/17772892) microcatheter.When the physician retracted the microcatheter to deploy the first enterprise 2 stent (enc401600/10715556), he was only able to visualize the tip of the delivery wire on fluoroscopy.Therefore, the enterprise 2 was removed from the prowler select plus microcatheter.The stent was still on the delivery wire upon removal from the patient.The enterprise 2 was replaced with a 4mm x 23mm enterprise 2 (enc402300/11020343), but the same issue occurred.The stent would not exit the distal tip of the microcatheter.Therefore, the enterprise 2 was removed from the microcatheter.The stent was still on the delivery wire upon removal.The enterprise 2 was replaced with a 4mm x 39mm enterprise 2 (enc403900/11001897), but the physician was only able to see the ¿fleared ends¿ of the stent.The stent would not exit the distal tip of the microcatheter.During withdrawal, the stent prematurely deployed in the hub of the microcatheter.The system was removed from the patient due to ¿safety reasons¿ and the physician decided to resort to percutaneous transluminal angioplasty (pta) without stenting.The procedure was delayed one hour due to the events, but it is not clear if the procedural delay was considered clinically significant.There was no report of patient injury and the patient¿s baseline condition did not worsen as a result of the events.Additional intervention was not required.There was no difficulty withdrawing the enterprise stents from the microcatheter.It was reported that an adequate and continuous flush was maintained through the catheter.The microcatheter did not appear damaged in any way and the same microcatheter was used to complete the procedure.The user had not applied undue force when handling the devices.No further information could be obtained.The 4mm x 23mm enterprise 2 stent was not returned for evaluation.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11020343.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the manufacturing process of the unit.Deployment difficulty is a known potential product failure associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Of note, the device was being used off-label to treat carotid artery stenosis.According to the ifu, the enterprise stent is intended for use with occlusive devices in the treatment of intracranial aneurysms and is not intended as a stand-alone device.Assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation and vessel characteristics, may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2019-00857.

• Brand Name: ENTERPRISE2 4MMX23MM NO TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8425501
• MDR Text Key: 138960672
• Report Number: 1226348-2019-00856
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: ENC402300
• Device Lot Number: 11020343
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1