MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EU ENT4.5MMD 37MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC453700

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(6).Device manufacturer date - not available at this time.The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.This is one of two products involved with the complaint and the associated manufacturer report number are 1226348-2019-01035.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by a healthcare professional, during a stent-coil embolization, a 4.5mmd 37mml enterprise stent delivery system (enc453700, 11175281) could not advance in the 150/5cm prowler select plus microcatheter (606s255x, 30254238).The physician withdrew the stent and microcatheter (mc) outside of the patient together.The cerebral target position was lost.There was no patient injury reported.The procedure was completed with new products.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this report: d4, d10, g4, g7, h2, h3, h4, h6 and h10.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-coil embolization, a 4.5mmd 37mml enterprise stent delivery system (enc453700,11175281) could not advance in the 150/5cm prowler select plus microcatheter (606s255x, 30254238).The physician withdrew the stent and micro catheter outside of the patient together.The cerebral target position was lost.There was no patient injury reported.The procedure was completed with new products.Additional information received indicated that other devices were successfully used with the prowler select prior to the encountered issue.No additional intervention was needed to remove the devices from the patient.A ¿little bit force¿ was used through the catheter pull back.Adequate flush was been maintained through the devices.The devices were not inspected prior to use.There was no significant clinical prolongation of the procedure due to the event.One non-sterile eu ent4.5mmd 37mml wno dstl tp unit was received inside of a pouch.The device was visually inspected, and the stent and the introducer were not returned for evaluation.No damages were noted on the delivery wire.The functional analysis could not be performed due to the introducer and the stent were not returned for evaluation.It is necessary that the stent is still inside of the introducer tube to perform the functional analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11175281.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint reported by the customer ¿delivery wire - impeded in microcatheter with loss of cerebral target position¿ was not confirm.Only the delivery wire was returned for evaluation and the functional analysis could not be performed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Impeded in microcatheter is a known potential issue associated with the use of the device.Impeded in microcatheter is a known potential product failure associated with the use of the device.The ifu includes warnings and instructions for use to trouble shoot this type of situation.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

Manufacturer Narrative

Product complaint # : (b)(4).Updated sections on this report: section b5, g4, g7, h2, and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section b5: additional information received indicated that other devices were successfully used with the prowler select prior to the encountered issue.No additional intervention was needed to remove the devices from the patient.A ¿little bit force¿ was used through the catheter pull back.Adequate flush was been maintained through the devices.The devices were not inspected prior to use.There was no significant clinical prolongation of the procedure due to the event.

• Brand Name: EU ENT4.5MMD 37MML 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: 9489714
• MDR Text Key: 205171417
• Report Number: 1226348-2019-01034
• 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,Followup
• Report Date: 12/11/2019

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: 07/28/2021
• Device Catalogue Number: ENC453700
• Device Lot Number: 11175281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/19/2019; 01/14/2020
• Supplement Dates FDA Received: 01/07/2020; 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM