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

Catalog Number	ENF403912
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device was available to be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
During the procedural, an enterprise stent (enf403912/ (b)(4)) did not deploy and flare well.It was reported that the microcatheter was partially deployed out of the prowler select plus (catalog/lot unk) microcatheter.The surgeon recaptured it and used another product to successfully complete the procedure.A continuous flush had been maintained through the microcatheter and the microcatheter did not appear damaged.Neither the stent or stent delivery system appeared damaged during the procedure.There were no potential patient adverse events and no delay in the procedure.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
Conclusion: during the procedure, an enterprise stent (enf403912/ 10749458) did not deploy and flare well.It was reported that the microcatheter was partially deployed out of the prowler select plus (catalog/lot unk) microcatheter.The surgeon recaptured it and used another product to successfully complete the procedure.A continuous flush had been maintained through the microcatheter and the microcatheter did not appear damaged.Neither the stent nor stent delivery system appeared damaged during the procedure.There were no potential patient adverse events and no delay in the procedure.A non-sterile enterprise and an unspecified microcatheter were received inside of a plastic bag.The delivery wire was inspected and it was found without any damage.The introducer tube and stent were not returned for evaluation.No damages were noted on the microcatheter received.The functional analysis could not be performed since the stent and introducer tube were not returned for evaluation 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 this complaint involved lot # 10749458.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 partial stent deployment could not be confirmed since the stent was not received.The device did not present any obvious indication of manufacturing defect or anomaly that could have 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.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6439101
• Report Number: 1226348-2017-00048
• Device Sequence Number: 16256924
• Product Code: NJE
• UDI-Device Identifier: 10886704075394
• UDI-Public: (01)10886704075394(17)190928(10)10749458
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2017

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: 09/28/2019
• Device Catalogue Number: ENF403912
• Device Lot Number: 10749458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 04/26/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER SELECT PLUS (CATALOG/LOT UNK)