MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC402300

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not 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 supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00417 and 3008114965-2020-00418.

Event Description

A report from the field indicated that during a balloon-assisted coil embolization of a right internal carotid-posterior communicating artery (ic-pc) artery aneurysm, a 9mm x 25cm galaxy g3 (gly120925/unknown lot #) was inserted and detached as the framing coil via an sl-10 (stryker) microcatheter.Next, unspecified ied (kaneka) and galaxy g3 coils were utilized for filling and finishing.One of the previously placed coil loops subsequently protruded into the parent vessel resulting in the need for stent-assisted coiling.The scepter c (terumo) balloon catheter was removed from the patient and a prowler select plus (unknown product code & lot #) microcatheter was delivered to the middle cerebral artery (mca).A 4mm x 23mm enterprise 2 no tip (enc402300/11138626) stent was inserted into the prowler select plus microcatheter.The physician attempted to implant the stent, but he could not see the marker.Although the inside of the skull including the distal part of the mca was photographed, there was no apparent sign that the stent was implanted.It had not deployed at the y-connector.The physician suspected that the complaint device did not have a marker, so he started to remove the device from the patient.The introducer sheath was retracted to the hub of a microcatheter along the delivery wire.However, the wire was not able to be re-sheathed inside the sheath.Therefore, the complaint device was removed from the hub.The enterprise was replaced with a same-sized stent.The markers of the replacement stent were able to be visualized via angiography and it was deployed at the neck of the aneurysm.The procedure was completed with no reported patient consequence.After the patient left the room, the physician examined the enterprise complaint device under fluoroscopy.Four platinum markers were observed at both ends, so no malfunction was identified in the main stent body.It was stated that ¿the delivery wire might have had any problems since it could not be delivered to the tip of the microcatheter¿.No further information was provided at the time of complaint initiation.Additional information received on 09-sep-2020 indicated that the coil that protruded from the aneurysm was the first framing coil, a 9mm x 25cm galaxy g3 (gly120925/unknown lot #).It was stated that ¿the large outer part of the coil mass just protruded to the neck side¿ and ¿it is not a product malfunction¿.The issue was resolved by packing the coil inside the wide-necked aneurysm; ¿it did not seem to be popping out like an apple¿s stem end.¿ no further information was provided.

Manufacturer Narrative

Product complaint #: (b)(4).Section b5: additional information received on 01-oct-2020 indicated that the event did not prolong the procedure.It was reported that the devices were used and prepped according to the instructions for use (ifu).There was an adequate flush maintained through the devices.Excessive force had not been applied to the devices.No further information could be obtained.Section e1-- initial reporter phone: (b)(6).Complaint conclusion: a report from the field indicated that during a balloon-assisted coil embolization of a right internal carotid-posterior communicating artery (ic-pc) artery aneurysm, a 9mm x 25cm galaxy g3 (gly120925/unknown lot #) was inserted and detached as the framing coil via an sl-10 (stryker) microcatheter.Next, unspecified ied (kaneka) and galaxy g3 coils were utilized for filling and finishing.One of the previously placed coil loops subsequently protruded into the parent vessel resulting in the need for stent-assisted coiling.The scepter c (terumo) balloon catheter was removed from the patient and a prowler select plus (unknown product code & lot #) microcatheter was delivered to the middle cerebral artery (mca).A 4mm x 23mm enterprise 2 no tip (enc402300/11138626) stent was inserted into the prowler select plus microcatheter.The physician attempted to implant the stent, but he could not see the marker.Although the inside of the skull including the distal part of the mca was photographed, there was no apparent sign that the stent was implanted.It had not deployed at the y-connector.The physician suspected that the complaint device did not have a marker, so he started to remove the device from the patient.The introducer sheath was retracted to the hub of a microcatheter along the delivery wire.However, the wire was not able to be re-sheathed inside the sheath.Therefore, the complaint device was removed from the hub.The enterprise was replaced with a same-sized stent.The markers of the replacement stent were able to be visualized via angiography and it was deployed at the neck of the aneurysm.The procedure was completed with no reported patient consequence.After the patient left the room, the physician examined the enterprise complaint device under fluoroscopy.Four platinum markers were observed at both ends, so no malfunction was identified in the main stent body.It was stated that ¿the delivery wire might have had any problems since it could not be delivered to the tip of the microcatheter¿.Additional information received on 09-sep-2020 indicated that the coil that protruded from the aneurysm was the first framing coil, a 9mm x 25cm galaxy g3 (gly120925/unknown lot #).It was stated that ¿the large outer part of the coil mass just protruded to the neck side¿ and ¿it is not a product malfunction¿.The issue was resolved by packing the coil inside the wide-necked aneurysm; ¿it did not seem to be popping out like an apple¿s stem end.¿ additional information received on 01-oct-2020 indicated that the event did not prolong the procedure.It was reported that the devices were used and prepped according to the instructions for use (ifu).There was an adequate flush maintained through the devices.Excessive force had not been applied to the devices.No further information could be obtained.One non-sterile unit enterprise2 4mmx23mm no tip was received inside of a pouch.The device was inspected, and it was noted that the introducer and delivery wire were separated in good normal conditions.The stent was not returned for evaluation.The functional analysis could not be performed due to only the delivery wire was returned for evaluation.It is necessary that the stent is still inside of the introducer tube to perform the functional analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11138626 the history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Delivery wire impeded and stent marker inadequate radiopacity are known potential procedural complications associated with the enterprise 2 stent.Neither the device history record review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.With the information provided, it is not possible to determine the root cause of the events; however, clinical and procedural factors may have contributed.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 4MMX23MM NO TIP
• 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: 10560561
• MDR Text Key: 252281828
• Report Number: 3008114965-2020-00417
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Catalogue Number: ENC402300
• Device Lot Number: 11138626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GALAXY G3 9MM X 25CM.; IED COMPETITOR COIL.; SCEPTERC, TERUMO BALLON CATHETER.; SL10, STRYKER MICROCATHETER.; UNKPROWLERSELECT.