MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PULSERIDER T, 3MM, 8MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Model Number 201-D

Device Problems Malposition of Device (2616); Difficult to Advance (2920)

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are 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.A review of manufacturing documentation associated with this lot (3051697022) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00276 and 3008114965-2021-00277.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 during a coil embolization procedure targeting an unruptured aneurysm at the middle cerebral artery (mca), a flexor® shuttle® guiding sheath (cook medical) was inserted from the right femoral artery and an approach was made toward the left internal carotid artery (ica).An sl-10® microcatheter (stryker) for the coil was approached to the aneurysm of the left mca.A guidepost was inserted from the side and the 150cm x 5cm prowler select plus microcatheter (606s255x / 30425324) approached near the aneurysm neck.The pulserider t 8mm arch, 2.7 to 3.5 mm aneurysm neck reconstruction device (anrd) (201d / 3051697022) was prepped and inserted into the prowler select plus microcatheter.The introducer was removed and the pulserider advanced approximately 5 to 10cm from the distal end of the microcatheter and there was intense resistance felt, but the physician was able to advance the pulserider.It was reported that the pulserider was not deployed well at the aneurysm neck region.The physician removed the pulserider and checked it; it appeared normal and was re-inserted but the resistance was felt even though the position of the distal access catheter (dac) was changed or the bend of the microcatheter became straightened, the resistance became stronger.Another 150cm x 5cm prowler select plus microcatheter from a different lot and another pulserider t 8mm arch, 2.7 to 3.5 mm (201d) were used as replacements without any issue.The procedure continued without any patient adverse event or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 10 august 2021.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00276 and 3008114965-2021-00277.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 the investigational finding of the returned device.[conclusion]: the healthcare professional reported during a coil embolization procedure targeting an unruptured aneurysm at the middle cerebral artery (mca), a flexor® shuttle® guiding sheath (cook medical) was inserted from the right femoral artery and an approach was made toward the left internal carotid artery (ica).An sl-10® microcatheter (stryker) for the coil was approached to the aneurysm of the left mca.A guidepost was inserted from the side and the 150cm x 5cm prowler select plus microcatheter (606s255x / 30425324) approached near the aneurysm neck.The pulserider t 8mm arch, 2.7 to 3.5 mm aneurysm neck reconstruction device (anrd) (201d / 3051697022) was prepped and inserted into the prowler select plus microcatheter.The introducer was removed and the pulserider advanced approximately 5 to 10cm from the distal end of the microcatheter and there was intense resistance felt, but the physician was able to advance the pulserider.It was reported that the pulserider was not deployed well at the aneurysm neck region.The physician removed the pulserider and checked it; it appeared normal and was re-inserted but the resistance was felt even though the position of the distal access catheter (dac) was changed or the bend of the microcatheter became straightened, the resistance became stronger.Another 150cm x 5cm prowler select plus microcatheter from a different lot and another pulserider t 8mm arch, 2.7 to 3.5 mm (201d) were used as replacements without any issue.The procedure continued without any patient adverse event or complication.The complaint device was returned and received for evaluation and analysis.The visual inspection finding is documented below.Investigation summary: the non-sterile pulserider t 8mm arch, 2.7 to 3.5 mm aneurysm neck reconstruction device was received contained in a pouch.Visual inspection was performed.The returned device was observed to be in good, normal condition.The implant component was still attached to the delivery wire inside the introducer.No damage nor anomaly was observed on the implant.Functional analysis: a lab sample microcatheter was used to perform the functional test due to the condition of the complaint 150cm x 5cm prowler select plus microcatheter with a compressed area at the tip section.The lab sample microcatheter was flushed with a syringe and the complaint pulserider t 8mm arch, 2.7 to 3.5 mm anrd was introduced into the microcatheter and advanced.There was no resistance friction felt during the advancement.A review of manufacturing documentation associated with this lot (3051697022) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint documented that during the coil embolization procedure, the pulserider t 8mm arch, 2.7 to 3.5 mm anrd was prepped and inserted into the prowler select plus microcatheter.The introducer was removed and the pulserider advanced approximately 5 to 10cm from the distal end of the microcatheter and there was intense resistance felt, but the physician was able to advance the pulserider.It was reported that the pulserider was not deployed well at the aneurysm neck region.The physician removed the pulserider and checked it; it appeared normal and was re-inserted but the resistance was felt even though the position of the distal access catheter (dac) was changed or the bend of the microcatheter became straightened, the resistance became stronger.The complaint device was returned and was observed to be in good condition.The implant was still attached to the delivery wire.It was introduced into a lab sample microcatheter and was advanced without any issue; no resistance friction was encountered.The reported issue was not confirmed.The pulserider t device performed without any difficulties.No appearance of damage nor anomaly was observed on the device.The resistance friction issue reported is most likely related to the observed compressed area of the prowler select plus microcatheter.As per the investigation performed on the returned prowler select plus microcatheter, the guidewire was introduced into the microcatheter lumen and there was resistance friction felt during the advancement of the guidewire.Although no issues were found on the device.The instructions for use (ifu) does contain the following recommendation: never advance or apply torque against resistance without careful fluoroscopic assessment of the cause.Movement against resistance may result in damage to the vessel or the device.If the cause cannot be determined, withdraw the device from the patient and replace with a new device.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.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00276.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: PULSERIDER T, 3MM, 8MM ARCH
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 12191696
• MDR Text Key: 280680334
• Report Number: 3008114965-2021-00276
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 00859030005154
• Combination Product (y/n): N
• PMA/PMN Number: H160002
• 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: 06/30/2021

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 Expiration Date: 01/31/2024
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: 3051697022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 08/10/2021; 09/07/2021
• Supplement Dates FDA Received: 08/10/2021; 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLEXOR® SHUTTLE® GUIDING SHEATH (COOK MEDICAL); PROWLER SELECT PLUS 150/5CM; SL-10® MICROCATHETER (STRYKER)