MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

Device Problems Premature Activation (1484); Activation Problem (4042)

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

Event Date 04/01/2022

Event Type  Injury  

Event Description

The healthcare professional reported that during a vascular stent placement in a (b)(6) male patient, the 4mm x 23mm enterprise 2 stent (encr402312 / 6441636) was positioned at the target lesion and the physician slightly released it but found that the proximal stent markers did not open; the distal stent markers opened upon deployment.The physician attempted to withdraw the enterprise 2 from the patient, however, the stent unintendedly deployed, not in the desired location.A new stent was implanted at the target site to complete the procedure.The procedure was delayed approximately 20 minutes due to the event.There was no report of patient injury.The enterprise 2 stent remains implanted in the patient and is thus not available for evaluation.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.Initial reporter phone: (b)(6).The initial reporter email address was not provided / reported.[conclusion]: the healthcare professional reported that during a vascular stent placement in a (b)(6) male patient, the 4mm x 23mm enterprise 2 stent (encr402312 / 6441636) was positioned at the target lesion and the physician slightly released it but found that the proximal stent markers did not open; the distal stent markers opened upon deployment.The physician attempted to withdraw the enterprise 2 from the patient, however, the stent unintendedly deployed, not in the desired location.A new stent was implanted at the target site to complete the procedure.The procedure was delayed approximately 20 minutes due to the event.There was no report of patient injury.The enterprise 2 stent remains implanted in the patient and is thus not available for evaluation.Based on complaint information, the device remains implanted and is thus not available for evaluation.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6441636.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.As a result, we are closing this investigation.Partial stent deployment is classified as an mdr reportable malfunction with the following rationale: if the stent was partially deployed, with vessel wall apposition obtained, and complete deployment was unsuccessful, removal of the stent delivery system (sds)/stent could result in dissection, perforation, or other vessel damage.Premature stent deployment in an unintended vessel could lead to damage of healthy intima, possible side branch occlusion, ischemia, infarct and/or the need for additional intervention.In this case, another stent was required to fully cover the target lesion and preclude patient injury.Thus, the event is considered mdr reportable as a ¿serious injury.¿ with the information available and without the complaint device available for analysis, the reported issues related to partial stent deployment and deployment difficulty could not be confirmed through product evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 15-may-2022.[additional information]: on 15-may-2022, additional information was received.The information indicated that the target vessel was the v4 segment of the right vertebral artery; the procedure was targeting a right vertebral artery stenosis.The blood vessels are relatively straight.The diameter of the distal vessel is 2.9mm, the diameter of the proximal vessel is 2.6mm.Anonymized images / angiographs of the procedure are not obtainable.The stent was released at the v3 segment of the right vertebral artery.The patient¿s baseline neurological status and after the event is reported as ¿no symptoms at this moment.¿ the patient is currently reported to be in stable condition.The event did not result in a stroke or a thrombotic event.The temperature indicator on the label of the inner pouch was checked and found to be within acceptable criteria.There was no resistance during the advancement of the 4mm x 23mm enterprise 2 stent.Vessel characteristics were not factors that may have contributed to the issue.There was no blood flow restriction / reduction due to reported event.The physician chose the appropriate size stent.The physician retracted the stent slightly to release it, and it was found that the stent proximal markers were unable to open (stent distal markers have been opened).Then the physician attempted to withdraw the stent, ¿at this moment, the stent released suddenly in the patient.¿ interaction with another device did not cause the migration.The physician used another 4mm x 23mm enterprise 2 stent (encr402312) to implant at the target site to complete the procedure.The information indicated that the 20-minute prolongation in the procedure was not considered clinically significant.The microcatheter used was the prowler select plus microcatheter.A.2: the additional information indicated that the patient¿s date of birth was (b)(6) 1966.The date was not reported.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: ENTERPRISE2 4MMX23MM
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14116273
• MDR Text Key: 293734703
• Report Number: 3008114965-2022-00266
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 6441636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 05/15/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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: PROWLER SELECT PLUS 150/5CM
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male