MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EU 4.5X28MM STENT 12 MM DW TIP; CODMAN ENTERPRISE

Catalog Number ENC452812

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 1226348-2019-00956 & 1226348-2019-00957.

Event Description

As reported by a healthcare professional, during a stent assist coil embolization to the posterior communicator, a 4.5x28 mm enterprise stent 12 mm dw tip (enc452812, 10911251) did not pass through a prowler select.21 microcatheter (606s255x lot 30148964).Both the enterprise stent delivery system and the prowler select were removed from the patient.It was noted that the enterprise stent presented ¿twisted, unraveled¿.For this reason, the stent did not advance successfully.There was no patient injury reported, treatment was achieved without any complications.They used two other stents for reasons of non-availability of the measure that was needed for the case.The introducer of the enterprise was fully seated and secured in the hub.The same surgical technique was used that normally the doctor has used in other successful cases.

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.Complaint conclusion: as reported by a healthcare professional, during a stent assist coil embolization to the posterior communicator, a 4.5x28mm enterprise stent 12 mm dw tip (enc452812, 10911251) did not pass through a prowler select.21 microcatheter (606s255x lot 30148964).Both the enterprise stent delivery system and the prowler select were removed from the patient.It was noted that the enterprise stent presented ¿twisted, unraveled¿.For this reason, the stent did not advance successfully.There was no patient injury reported, treatment was achieved without any complications.They used two other stents for reasons of non-availability of the measure that was needed for the case.The introducer of the enterprise was fully seated and secured in the hub.The same surgical technique was used that normally the doctor has used in other successful cases.The 4.5x28mm enterprise stent 12 mm dw tip was not returned for analysis and therefore, no further investigation can be performed at this time.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 10911251.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 complaints of ¿delivery wire - impeded in microcatheter with loss of cerebral target position¿ and ¿stent- kinked/bent¿ could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the events are related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.The instructions for use (ifu) warns that if the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: EU 4.5X28MM STENT 12 MM DW TIP
• Type of Device: CODMAN ENTERPRISE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8800030
• MDR Text Key: 151355501
• Report Number: 1226348-2019-00956
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2019
• Device Catalogue Number: ENC452812
• Device Lot Number: 10911251
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 0.21 MICROCATHETER; PROWLER SELECT PLUS 0.21 MICROCATHETER
• Patient Age: 47 YR