MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X28MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452812

Device Problems Retraction Problem (1536); Difficult to Advance (2920); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  malfunction  

Event Description

The healthcare professional reported that during a stent-assisted aneurysm embolization procedure, it was reported that the 4.5mm x 28mm enterprise® vascular reconstruction device (enc452812 / 6187541) was advanced through the 150cm x 5cm, 2 markers prowler select plus microcatheter (606s255x / 30508771) and arrived at the target position, the delivery wire of the stent¿s tip passed through the microcatheter but the stent body could not be released; the delivery wire can be withdrawn.After several attempts, the stent still could not be released.The physician withdrew the stent and the microcatheter together from the patient.A new microcatheter and a new stent were used to complete the procedure.There was no report of any patient adverse event or complication associated with the reported issue.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Initial reporter phone: (b)(6).The initial reporter email address is not available / reported.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.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6187541.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00339.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 01 september 2021.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: d.9, g.3, g.6.H.2, h.3, h.6, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00338 and 3008114965-2021-00339.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.

Manufacturer Narrative

Manufacturer¿s ref.No:(b)(4).The purpose of this mdr submission is to include the additional event information received on 17 august 2021.[additional information]: the healthcare professional reported that during a stent-assisted aneurysm embolization procedure, it was reported that the 4.5mm x 28mm enterprise® vascular reconstruction device (enc452812 / 6187541) was advanced through the 150cm x 5cm, 2 markers prowler select plus microcatheter (606s255x / 30508771) and arrived at the target position, the delivery wire of the stent¿s tip passed through the microcatheter but the stent body could not be released; the delivery wire can be withdrawn.After several attempts, the stent still could not be released.The physician withdrew the stent and the microcatheter together from the patient.A new microcatheter and a new stent were used to complete the procedure.There was no report of any patient adverse event or complication associated with the reported issue.On 17 august 2021, additional information was received.The information indicated that the patient is a 71-year-old female.There was no visible kinks nor other damages on the microcatheter.It is not certain if there was any issue with the microcatheter as related to the enterprise stent.The enterprise stent was not able to be advanced nor retracted in the prowler select plus microcatheter.When the enterprise stent was removed from the patient, it was still on the delivery wire.The information indicated that nothing unusual was noted on the microcatheter nor on the enterprise system prior to use.The physician removed the microcatheter even though the delivery wire can be withdrawn because he was not sure if the issue was related to the enterprise stent or to the prowler select plus microcatheter.Adequate and continuous flush was maintained through the microcatheter.The procedure was completed using competitor stent and microcatheter.There was no prolongation of the procedure due to the reported event.Updated sections: a.2, a.3, g.3, g.6, h.2, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00338 and 3008114965-2021-00339.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.

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 a stent-assisted aneurysm embolization procedure, it was reported that the 4.5mm x 28mm enterprise® vascular reconstruction device (enc452812/6187541) was advanced through the 150cm x 5cm, 2 markers prowler select plus microcatheter (606s255x /30508771) and arrived at the target position, the delivery wire of the stent¿s tip passed through the microcatheter but the stent body could not be released; the delivery wire can be withdrawn.After several attempts, the stent still could not be released.The physician withdrew the stent and the microcatheter together from the patient.A new microcatheter and a new stent were used to complete the procedure.There was no report of any patient adverse event or complication associated with the reported issue.On 17 august 2021, additional information was received.The information indicated that the patient is a 71-year-old female.There was no visible kinks nor other damages on the microcatheter.It is not certain if there was any issue with the microcatheter as related to the enterprise stent.The enterprise stent was not able to be advanced nor retracted in the prowler select plus microcatheter.When the enterprise stent was removed from the patient, it was still on the delivery wire.The information indicated that nothing unusual was noted on the microcatheter nor on the enterprise system prior to use.The physician removed the microcatheter even though the delivery wire can be withdrawn because he was not sure if the issue was related to the enterprise stent or to the prowler select plus microcatheter.Adequate and continuous flush was maintained through the microcatheter.The procedure was completed using competitor stent and microcatheter.There was no prolongation of the procedure due to the reported event.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 150cm x 5cm, 2 markers prowler select plus microcatheter was received coiled and contained in a pouch.The 4.5mm x 28mm enterprise® vascular reconstruction stent is stuck inside the microcatheter; the stent is stuck at the tip section and could not be removed.Residues of dried saline solution were observed on the tip and the stent.This observation could likely be the cause of the stent component being stuck in the microcatheter.Visual inspection of the stent could not be performed.Functional evaluation: the prowler select plus microcatheter was flushed with warm water in attempt to remove the stent from the microcatheter.However, the stent component could not be removed.The microcatheter was inspected and there were no appearance of damages noted.Residues of dried saline were observed which likely contributed to the stent component being stuck inside the microcatheter.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6187541.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint reported that during a stent-assisted aneurysm embolization procedure, the 4.5mm x 28mm enterprise® vascular reconstruction device was not able to be advanced nor retracted in the 150cm x 5cm, 2 markers prowler select plus microcatheter.When the enterprise stent was removed from the patient with the microcatheter, it was still on the delivery wire.Nothing unusual was observed on the microcatheter; it was removed even though the delivery wire was able to be withdrawn because the physician was not sure if the issue was related to the stent or to the microcatheter.The 4.5mm x 28mm enterprise stent was returned stuck inside the prowler select plus microcatheter with residues of dried saline solution observed on the micrococatheter and on stent.No damage was observed on the microcatheter.This is consistent with the information documented in the complaint, that nothing unusual was observed on the microcatheter.The microcatheter was flushed but the stent component could not be removed which precluded functional evaluation on the stent component.Based on the condition of the stent being stuck inside the tip of the microcatheter and with the residues of dried saline solution observed, the reported issue is confirmed.Adequate and continuous flush had been maintained through the microcatheter, thus, the exact cause of the stent becoming stuck and the reported issue documented in the complaint cannot be determined.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.It should be noted that product failure is multifactorial, the instructions for use (ifu) contains the following warnings and recommendations: do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.If resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.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.H6: the code ¿no device problem found¿ code was used in investigation findings to indicate that the due to the stent component being stuck inside the microcatheter and could not be removed, functional testing could not be performed.The code ¿cause not established¿ was used in investigation conclusions is corresponding to the code ¿no device problem found¿ as related to these issues.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00338 and 3008114965-2021-00339.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 4.5X28MM STENT 12 MM DW TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 12316823
• MDR Text Key: 280703020
• Report Number: 3008114965-2021-00338
• 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,Followup,Followup
• Report Date: 07/26/2021

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: 12/28/2022
• Device Catalogue Number: ENC452812
• Device Lot Number: 6187541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 08/17/2021; 09/01/2021; 09/16/2021
• Supplement Dates FDA Received: 08/18/2021; 09/01/2021; 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM
• Patient Age: 71 YR