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

Catalog Number 201D

Device Problem Separation Failure (2547)

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

Event Date 04/14/2022

Event Type  Injury  

Event Description

It was reported by a healthcare professional that during a coil embolization of a left middle cerebral artery (mca) aneurysm, an error occurred when the operator attempted to detach the pulserider 8t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd).Details of the procedure: approach was made from the right femoral artery (fa) with an 8f sheath (brand/manufacturer not specified).The 8f roadmaster guiding catheter (goodman) was approached to the left internal carotid artery (ica).From there, the 6f navien distal access catheter (dac) was advanced to the posterior communicating artery (p-com), and the prowler select plus microcatheter (unknown product code & lot number) was approached to the target aneurysm.The pulserider anrd was inserted and deployed via the above-mentioned route, but the direction did not match as the physician intended, and therefore the device was reinserted about four times.As a result, the device was positioned in the ideal direction.Next, coil embolization was performed with four coils (brand/manufacturer not specified).After that, the power was energized by connecting the power cable in an attempt to detach the complaint device.The first cycle took about 30 seconds.It was a normal reaction of detachment, therefore, when it was energized again, an error occurred ¿because it seemed to have been detached at the 1st time (red blinking)¿.¿on fluoroscopy, the leg moved during the second energization, therefore, it was visible under fluoroscopy as if it was detached off.¿ the physician tried to advance the concomitant prowler select plus microcatheter to check if the leg did not move; the tip of the prowler select plus microcatheter moved to one leg, but the physician thought it was due to blood vessel tortuosity.The delivery wire of the complaint device was retracted.At that time, ¿the leg in one direction was not detached¿, and the entire pulserider anrd ended up moving.The coil came out from the neck slightly.When energized again, both legs were finally detached.Since the coil protruded out of the aneurysm, an atlas stent (stryker) was implanted from the inferior trunk to the m1 segment.The coil was pressed down without any issues, the procedure was completed.There was no report of patient injury.Continuous flush was done.No further information was provided.

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 device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 3070988516 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.

Manufacturer Narrative

Product complaint # (b)(4).Updated section on this medwatch report: b4, e1, e2, e3, g3, g6, h2 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section e1.Initial reporter phone: (b)(6).Complaint conclusion: it was reported by a healthcare professional that during a coil embolization of a left middle cerebral artery (mca) aneurysm, an error occurred when the operator attempted to detach the pulserider 8t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd).Details of the procedure: approach was made from the right femoral artery (fa) with an 8f sheath (brand/manufacturer not specified).The 8f roadmaster guiding catheter (goodman) was approached to the left internal carotid artery (ica).From there, the 6f navien distal access catheter (dac) was advanced to the posterior communicating artery (p-com), and the prowler select plus microcatheter (unknown product code & lot number) was approached to the target aneurysm.The pulserider anrd was inserted and deployed via the above-mentioned route, but the direction did not match as the physician intended, and therefore the device was reinserted about four times.As a result, the device was positioned in the ideal direction.Next, coil embolization was performed with four coils (brand/manufacturer not specified).After that, the power was energized by connecting the power cable in an attempt to detach the complaint device.The first cycle took about 30 seconds.It was a normal reaction of detachment, therefore, when it was energized again, an error occurred ¿because it seemed to have been detached at the 1st time (red blinking)¿.¿on fluoroscopy, the leg moved during the second energization, therefore, it was visible under fluoroscopy as if it was detached off.¿ the physician tried to advance the concomitant prowler select plus microcatheter to check if the leg did not move; the tip of the prowler select plus microcatheter moved to one leg, but the physician thought it was due to blood vessel tortuosity.The delivery wire of the complaint device was retracted.At that time, ¿the leg in one direction was not detached¿, and the entire pulserider anrd ended up moving.The coil came out from the neck slightly.When energized again, both legs were finally detached.Since the coil protruded out of the aneurysm, an atlas stent (stryker) was implanted from the inferior trunk to the m1 segment.The coil was pressed down without any issues, the procedure was completed.There was no report of patient injury.Continuous flush was done.There was no alleged product malfunction with the prowler select plus microcatheter.No further information is available.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 3070988516 number, and no non-conformances related to the malfunction were identified.Failure of the device to detach is a known potential product failure associated with the device.Per the pulserider instructions for use (ifu): do not fully deploy and retrieve the implant more than 3 times.Excessive deployment cycles of the anchor section of the pulserider may reduce the radial force of the device which could impact the implant stability.Increased detachment time may occur when the delivery wire and microcatheter markers are not properly positioned, there is improper setup of continuous flush, embolic coils are present, or connections between detachment power supply and delivery wire or patien¿s groin (return electrode) are poor.With the amount of information available and without the device for analysis, it is not possible to draw a conclusion between the device and the reported event.However, there are clinical, procedural factors, including vessel characteristics, device interaction, device selection, and operator technique that may have contributed to the event.The alleged device failure required stent implantation to secure the protruded coil and preclude patient harm.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: 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
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14304765
• MDR Text Key: 292985436
• Report Number: 3008114965-2022-00322
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 859030005154
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H160002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201D
• Device Lot Number: 3070988516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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: 6F NAVIEN DISTAL ACCESS CATHETER (DAC).; 8F ROADMASTER GUIDING CATHETER (GOODMAN).; UNKPROWLERSELECT.; UNSPECIFIED 8F SHEATH.
• Patient Outcome(s): Required Intervention