MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR403012

Device Problems Premature Activation (1484); Failure to Advance (2524)

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

Event Date 10/12/2022

Event Type  malfunction  

Event Description

As reported by the field, during a stent assist coil embolization, an enterprise2 4mmx30mm intracranial stent (encr403012, 6998484) became impeded in a non-j&j microcatheter (mc) and could not advance anymore.The physician retracted the stent and observed the stent was released.A new device was switched to complete the surgery.There was no patient injury reported.

Manufacturer Narrative

Product complaint#: (b)(4).Initial reporter name and address: initial reporter phone: (b)(6).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.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #(b)(4).Section b5: additional information received indicated that no excessive force was applied to the device at any time.The introducer was fully seated and secured in the hub.They were not able to torque the device.There was no evidence of physical material within the device.The resistance was encountered on the distal tip.No other devices had been successfully used with the concomitant device prior to or after the encountered resistance.The replacement stent was not of the same size as the original one.There were no procedural delays due to the event.Complaint conclusion: as reported by the field, during a stent assist coil embolization, an enterprise2 4mmx30mm intracranial stent (encr403012, 6998484) became impeded in a non-j&j microcatheter (mc) and could not advance anymore.The physician retracted the stent and observed the stent was released.A new device was switched to complete the surgery.There was no patient injury reported.Additional information received indicated that no excessive force was applied to the device at any time.The introducer was fully seated and secured in the hub.They were not able to torque the device.There was no evidence of physical material within the device.The resistance was encountered on the distal tip.No other devices had been successfully used with the concomitant device prior to or after the encountered resistance.The replacement stent was not of the same size as the original one.There were no procedural delays due to the event.A non-sterile enterprise2 4mmx30mm and two non-j&j balloon catheters (sinomed) were received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that only the delivery wire was returned for evaluation; it was found to be undamaged (i.E., no kinks, no fractures, nor separations).Both of the non-j&j balloon catheters were inspected, and the stent was not found inside them.The inner diameter was measured in order to verify the compatibility with the involved enterprise, and these measured 0.125 inches, which demonstrates that these are not compatible with the microcatheter recommended for the enterprise.The functional analysis could not be performed with a lab sample microcatheter since only the delivery wire was returned for evaluation.The stent must be inside the introducer to perform the functional analysis.The issue documented that the stent became impeded in the concomitant microcatheter could not be evaluated through functional testing since the stent had already been released from the unit; however, the usage of non-compatible microcatheters may have led to the issue encountered during the procedure.The stent detachment is considered to be secondary to the manipulation required to overcome the resistance during the stent removal.Based on this condition, the customer complaint regarding the stent release was confirmed.The stent component might have gotten lost during the post-operative handling of the device and did not reach the laboratory for evaluation.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of lot 6998484.The historical record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.It should be noted that product failure could be caused by multiple factors; the instructions for use contain the following warning: the codman enterprise vascular reconstruction device and delivery system is designed for use under fluoroscopy with the prowler® select¿ plus infusion catheter (a 0.021" inner diameter, 5 cm distal length infusion catheter manufactured by codman & shurtleff, inc.) compatibility with other infusion catheters has not been established.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX30MM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15708527
• MDR Text Key: 307265110
• Report Number: 3008114965-2022-00695
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

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 Catalogue Number: ENCR403012
• Device Lot Number: 6998484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NON J&J MICROCATHETER