MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452212

Device Problems Failure to Advance (2524); Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, weight, race, ethnicity, and medical history were not provided.The product lot number is not available / not reported.The expiration date of the device is not known.The 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.The device manufacture date is not known as the product lot number of the device is not available / not reported.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 aneurysm embolization procedure, after the physician advanced the 4.5mm d 22mm l reg enterprise® stent (encr452212 / lot# unknown) in the microcatheter for a moment, the physician found the stent had become impeded in the microcatheter.He tried to pull the stent back a little, but the stent unexpectedly and prematurely deployed in the concomitant microcatheter.The physician withdrew the stent and the microcatheter out of the patient.A new stent was used with the same microcatheter to complete the procedure.There was no report of any patient adverse event or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to make a correction to the section d.Suspect medical device.The affiliate added information that the correct device catalog is enc452212.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 returned complaint device on 10/12/2020; the returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that during the aneurysm embolization procedure, after the physician advanced the 4.5mm d 22mm l reg enterprise® stent (encr452212 / lot# unknown) in the microcatheter for a moment, the physician found the stent had become impeded in the microcatheter.He tried to pull the stent back a little, but the stent unexpectedly and prematurely deployed in the concomitant microcatheter.The physician withdrew the stent and the microcatheter out of the patient.A new stent was used with the same microcatheter to complete the procedure.There was no report of any patient adverse event or complication.The device was returned and received for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 4.5mm d 22mm l reg enterprise® stent was received contained in a pouch.Visual inspection was performed.The stent component was returned detached from the rest of the device.The delivery wire and the introducer were found in good, normal condition.No other damages nor anomalies were observed.Functional testing was not conducted; the stent was returned detached from the device.The stent needs to be inside the introducer tube in order for the device to undergo functional evaluation.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.The complaint documented that during the procedure, after the physician advanced the enterprise stent into the microcatheter for a moment, the stent became impeded in the microcatheter.The physician tried to pull the stent back a little, but it unexpectedly became prematurely deployed in the microcatheter.The stent was returned detached from the rest of the device, there is no evidence that the premature detachment occurred in the microcatheter.However, the condition of the returned stent, detached from the rest fo the device was confirmed.The lot number of the device is not known, therefore review of the device history record was not performed.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 4.5X22MM STENT 12 MM DW TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel MA CH-24 00; SZ CH-2400
• MDR Report Key: 10567831
• MDR Text Key: 222694411
• Report Number: 1226348-2020-00458
• 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
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1