MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX30MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	ENF403012
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the stent assisted coiling procedure, the 4.0 mm dia x 30 mm enterprise®2 stent (enf403012 / 11020342) was reported as prematurely deployed.There was no report of any patient consequence associated with the reported event.It was reported that the device is available to be returned for evaluation and analysis.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to make a correction to the manufacture information in section g, and to report that the product was received by cerenovus product analysis lab on 05/06/2019.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the stent assisted coiling procedure, the 4.0 mm dia x 30 mm enterprise®2 stent (enf403012 / 11020342) was reported as prematurely deployed.There was no report of any patient consequence associated with the reported event.Multiple attempts were made to obtain additional information related to the procedure and the reported device were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The 4.0 mm dia x 30 mm enterprise®2 stent was returned for evaluation.The investigational finding is documented below.Investigation summary: the non-sterile 4.0 mm dia x 30 mm enterprise®2 stent was received contained in a pouch.Visual inspect was performed.The delivery wire was observed to be in good condition.The introducer was inspected, and no appearance of damage was observed.The actual stent was not received.Without the return of the stent, the device received could not undergo functional testing.A review of manufacturing documentation associated with this lot (11020342) presented no issues during the manufacturing or inspection processes related to the reported complaint.The device history records indicate that this product underwent final inspection testing at lake region medical and was determined to be acceptable.The device component was returned without the actual stent component functional test could not be conducted and the reported issue that the 4.0 mm dia x 30 mm enterprise®2 stent prematurely deployed during the procedure could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation interaction 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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: ENTERPRISE2 4MMX30MM
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8474425
• Report Number: 1226348-2019-00871
• Device Sequence Number: 1473787
• Product Code: NJE
• UDI-Device Identifier: 10886704075370
• UDI-Public: 10886704075370
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: ENF403012
• Device Lot Number: 11020342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 05/06/2019; 06/05/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 05/06/2019; 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1