MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Model Number	641CF1030
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Hold gn 2-23-22 it was reported by a healthcare professional that during a stent-assisted coil embolization of a vertebral artery dissecting aneurysm, the opening of the proximal portion of the 4mm x 30mm enterprise 2 stent (enc403000/5711194) was poor.It was stated that there was a possibility that the stent was stuck in the narrowed area.The flare on the front side seemed to be hard to expand despite fully deployment.Therefore, a syouryu balloon catheter was used in an attempt to expand the stent.However, the flare of the stent became damaged because the ¿wire in the front side was sticking together¿.A snare device was then used in attempt to retrieve the device and the stent was grasped by the snare from the distal end, but ¿it came off on the way¿; ¿it became the state that floating in the air¿.The physician then tried to use a 6mm solitaire stent retriever, but the stent was not able to be pulled.However, since the flare at the proximal portion was deformed, the physician was finally able to grasp it with a snare and remove it.The enterprise complaint device was replaced with a neuroform atlas (stryker) stent.Coils were subsequently implanted, and the procedure was completed without any untoward events.There was no report of patient injury.Concomitant devices included a prowler select plus microcatheter (606-s255fx/30545428).Additional information received indicated that there was no report of resistance encountered during advancement of the enterprise system.It was reported that the stent may have become hooked onto vessel stenosis.The treating physician did not feel that the prolongation of procedure was clinically significant.Procedural imaging is not available for evaluation.The temperature indicator label on the device's inner pouch was checked and found to be within acceptable criteria.There was no evidence of blood flow restriction as a result of the event.
Additional Manufacturer Narrative
(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # = >(b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h6, h10 and concomitant products.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported by a healthcare professional that during a stent-assisted coil embolization of a vertebral artery dissecting aneurysm, the opening of the proximal portion of the 4mm x 30mm enterprise 2 stent (enc403000/5711194) was poor.It was stated that there was a possibility that the stent was stuck in the narrowed area.The flare on the front side seemed to be hard to expand despite fully deployment.Therefore, a syouryu balloon catheter was used in an attempt to expand the stent.However, the flare of the stent became damaged because the ¿wire in the front side was sticking together¿.A snare device was then used in attempt to retrieve the device and the stent was grasped by the snare from the distal end, but ¿it came off on the way¿; ¿it became the state that floating in the air¿.The physician then tried to use a 6mm solitaire stent retriever, but the stent was not able to be pulled.However, since the flare at the proximal portion was deformed, the physician was finally able to grasp it with a snare and remove it.The enterprise complaint device was replaced with a neuroform atlas (stryker) stent.Coils were subsequently implanted, and the procedure was completed without any untoward events.There was no report of patient injury.Concomitant devices included a prowler select plus microcatheter (606-s255fx/30545428).Additional information received indicated that there was no report of resistance encountered during advancement of the enterprise system.It was reported that the stent may have become hooked onto vessel stenosis.The treating physician did not feel that the prolongation of procedure was clinically significant.The temperature indicator label on the device's inner pouch was checked and found to be within acceptable criteria.There was no evidence of blood flow restriction as a result of the event the device remains implanted; therefore, no further investigation can be performed.A review of the manufacturing documentation associated with this lot 5711194 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Incomplete stent expansion requiring additional intervention is a known potential complication associated with the enterprise 2 vascular reconstruction device (vrd).With the information provided and without the return of the procedural imaging and the complaint device, it is not possible to determine the root cause of the event.However, there are clinical and procedural factor factors including aneurysm/vessel characteristics (i.E., vessel stenosis), device selection, and operator technique that may have contributed rather than the design or manufacture of the device.The file will be re-reviewed if additional information is received at a later date.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: ENTERPRISE2 4MMX30MM NO TIP
• Common Device Name: 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13583832
• Report Number: 3008114965-2022-00139
• Device Sequence Number: 5681277
• Product Code: NJE
• UDI-Device Identifier: 10878528009655
• UDI-Public: 10878528009655
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 641CF1030
• Device Catalogue Number: ENC403000
• Device Lot Number: 5711194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 03/26/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER SEL PLUS 150/5CM 45TIP; PROWLER SEL PLUS 150/5CM 45TIP; SYOURYU BALLOON CATHETER; UNSPECIFIED SNARE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown