MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EU ENT4.5MMD 28MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452800

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.The product was returned for evaluation and analysis.A supplemental 3500a report will be submitted once the product investigation has been completed.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.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 Description

The healthcare professional reported that during the interventional surgery procedure, the 4.5 mm x 28 mm enterprise® vascular reconstruction device (b)(4) became stuck in the middle of the prowler select plus microcatheter; adequate and continuous flush was maintained through the microcatheter.It was reported that there was nothing unusual noted on the stent system prior to use, there was no appearance of any damage on the stent or the stent delivery system.The physician could not withdraw nor advance the stent.The microcatheter was not obstructed.As a result, the microcatheter was withdrawn with the stent as a unit and the target position was lost.It was reported that the microcatheter did not have any kinks or other appearance of damage on it; the same microcatheter was used to complete the procedure with a new stent.It was reported that the patient¿s vasculature is normal.There was no report of patient injury or adverse event.

Manufacturer Narrative

Manufacturer¿s ref.(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 interventional surgery procedure, the 4.5mm x 28mm enterprise® vascular reconstruction device (enc452800 / 11017349) became stuck in the middle of the prowler select plus microcatheter; adequate and continuous flush was maintained through the microcatheter.It was reported that there was nothing unusual noted on the stent system prior to use, there was no appearance of any damage on the stent or the stent delivery system.The physician could not withdraw nor advance the stent.The microcatheter was not obstructed.As a result, the microcatheter was withdrawn with the stent as a unit and the target position was lost.It was reported that the microcatheter did not have any kinks or other appearance of damage on it; the same microcatheter was used to complete the procedure with a new stent.It was reported that the patient¿s vasculature is normal.There was no report of patient injury or adverse event.The product was returned for evaluation.The investigational finding is documented below.Investigation summary: the non-sterile 4.5mm x 28mm enterprise device was received contained in a pouch.Visual inspection was performed, and it was noted that the device was returned without the actual enterprise stent.Functional testing was not performed on the incomplete device returned.The reported issue that the enterprise stent was impeded in the microcatheter could not be confirmed as the stent and the concomitant microcatheter was not returned.A review of manufacturing documentation associated with this lot (11017349) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.With the information available and without the actual enterprise stent and concomitant microcatheter available for analysis, the reported customer complaint that the stent became stuck in the middle of the microcatheter could not be confirmed through functional analysis.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: EU ENT4.5MMD 28MML WNO DSTL TP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8828937
• MDR Text Key: 152330102
• Report Number: 1226348-2019-00954
• 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
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Catalogue Number: ENC452800
• Device Lot Number: 11017349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1