MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PULSERIDER T, 4MM, 10MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Model Number	213-D
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from a personal interaction that a patient underwent an endovascular embolization procedure for an aneurysm in the internal carotid artery.Per event description, the 4mm x 10mm pulserider t-arch (213d/ 3077440602) aneurysm neck reconstruction device (anrd) was delivered using a guidepost intermediate catheter and a prowler select plus microcatheter.It was reported that the pulserider was implanted but not detached.The physician then started winding the first coil (12x40 target) from the sl-10 microcatheter using the transcell technique.The coil loop was then caught by the pulserider; hence resheathing the coil became difficult.The physician attempted to untangle the coil and pulserider however the latter moved.As a result, the physician decided to retract the pulserider and the coil into the guiding catheter and were removed from the patient¿s body.The physician inspected the devices, and it was noticed that the pulserider was deformed.The device was not reused and discarded.The physician proceeded with the surgery, using a balloon-assisted approach this time and the procedure was completed.A continuous flush was performed during the surgery.No patient injury was reported.No other information was provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.
Additional Manufacturer Narrative
Product complaint (b)(4).The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3077440602 number, and no non-conformances related to the malfunction were identified.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Section b5: additional information was received on 17-november-2022.Summary of additional information provided: no resistance was noted during the attempt to recapture the pulserider.There were no significant procedural delay due to the issues or prolonged hospitalization due to the event.There were no issues encountered with the prowler select plus microcatheter (product/lot number not available).The patient's condition after the surgery was stable.No patient demographics were provided.Section e1.Initial reporter phone: (b)(6).Section 6.Medical device problem code: with the additional information received on 17-nov-2022, retraction problem (a0510) was removed as a medical device problem.Complaint conclusion: it was reported from a personal interaction that a patient underwent an endovascular embolization procedure for an aneurysm in the internal carotid artery.Per event description, the 4mm x 10mm pulserider t-arch (213d/ 3077440602) aneurysm neck reconstruction device (anrd) was delivered using a guidepost intermediate catheter and a prowler select plus microcatheter.It was reported that the pulserider was implanted but not detached.The physician then started winding the first coil (12x40 target) from the sl-10 microcatheter using the transcell technique.The coil loop was then caught by the pulserider; hence resheathing the coil became difficult.The physician attempted to untangle the coil and pulserider however the latter moved.As a result, the physician decided to retract the pulserider and the coil into the guiding catheter and were removed from the patient¿s body.The physician inspected the devices, and it was noticed that the pulserider was deformed.The device was not reused and discarded.The physician proceeded with the surgery, using a balloon-assisted approach this time and the procedure was completed.A continuous flush was performed during the surgery.No patient injury was reported.Additional information was received indicating that there was no resistance was noted during the attempt to recapture the pulserider.There were no significant procedural delay due to the issues or prolonged hospitalization due to the event.There were no issues encountered with the prowler select plus microcatheter (product/lot number not available).The patient's condition after the surgery was stable.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3077440602 number, and no non-conformances related to the malfunction were identified.Based on the information provided, a damaged pulserider device carries the risk of having the device being separated during the surgery and/or may even cause vessel damage.Therefore, it poses a risk of leading to a serious injury such as cerebral thrombosis.In addition, the entanglement of the pulserider with the coil and the attempt to recapture the device poses a risk of prolonging the surgery.Although the attempt in the end to recapture the device was successful, it still required the removal of the whole system hence there is the loss of cerebral access to the target lesion.This resulted to the treating physician modifying the original planned procedure by adding the use of a balloon.Therefore, these events meet the mdr reportability criteria.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: PULSERIDER T, 4MM, 10MM ARCH
• 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 & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15580612
• Report Number: 3008114965-2022-00653
• Device Sequence Number: 14998566
• Product Code: NJE
• UDI-Device Identifier: 00859030005123
• UDI-Public: 00859030005123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: H160002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 213-D
• Device Catalogue Number: 213D
• Device Lot Number: 3077440602
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 10/12/2022; 11/17/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 10/25/2022; 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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: 12X40 TARGET COIL,; GUIDEPOST INTERMEDIATE CATHETER,; PROWLER SELECT PLUS MICROCATHETER,; SL-10 MICROCATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown