MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKENTERPRISE2; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE2

Device Problem Patient-Device Incompatibility (2682)

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

Event Type  Injury  

Event Description

The healthcare professional reported that during a stent-assisted coil embolization of an acute cerebral aneurysm, a 2mm x 3cm galaxy g3 mini coil (glm920030 / unknown lot number) was intendedly detached, but the coil deviated outside of the aneurysm.The herniated coil was removed from the patient safely using a snare, and the procedure was completed without any untoward events.There was no report of patient injury.The complaint documented that a galaxy g3 (size unknown) was implanted at the target aneurysm, and an enterprise 2 stent (unknown product code and lot number) was then deployed.Next, the physician detached the complaint coil, however, the coil protruded out of the aneurysm into the parent artery.The complaint device is not available for evaluation.The complaint device is not available for evaluation.On 14-feb-2022, additional information was received.The information indicated that anonymized images / angiographs of the procedure are not available.The intended procedure was a stent-assisted coil embolization procedure.The target aneurysm was acute, but not ruptured.The reported event did not result in any clinically significant delay in the procedure.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Date of event: the date of the event is not known.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.The initial reporter phone: (b)(6).The initial reporter email address is not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that during a stent-assisted coil embolization of an acute cerebral aneurysm, a 2mm x 3cm galaxy g3 mini coil (glm920030 / unknown lot number) was intendedly detached, but the coil deviated outside of the aneurysm.The herniated coil was removed from the patient safely using a snare, and the procedure was completed without any untoward events.There was no report of patient injury.The complaint documented that a galaxy g3 (size unknown) was implanted at the target aneurysm, and an enterprise 2 stent (unknown product code and lot number) was then deployed.Next, the physician detached the complaint coil, however, the coil protruded out of the aneurysm into the parent artery.The complaint device is not available for evaluation.The complaint device is not available for evaluation.On 14-feb-2022, additional information was received.The information indicated that anonymized images / angiographs of the procedure are not available.The intended procedure was a stent-assisted coil embolization procedure.The target aneurysm was acute, but not ruptured.The reported event did not result in any clinically significant delay in the procedure.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.The device is not available to be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As a result, we are closing this investigation.Coil protrusion into parent vessel is a known potential complication associated with the use of the galaxy g3 mini coil and enterprise 2 vascular reconstruction device (vrd) in stent-assisted coil embolization procedures.With the amount of information available and without procedural films, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors including aneurysm/vessel characteristics, device selection, device interaction, and operator technique that may have contributed rather than the design or manufacture of the device.Since the event required additional intervention (i.E., use of a snare) to preclude patient complications such as non-target site embolization, ischemia, or infarct, the event is classified as serious and mdr reportable for both the galaxy g3 mini coil and the enterprise 2 vrd.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 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00095.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information will be submitted within 30 days of receipt.

• Brand Name: UNKENTERPRISE2
• 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 AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 13579337
• MDR Text Key: 290464444
• Report Number: 3008114965-2022-00096
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: GALAXY G3 MINI 2MM X 3CM
• Patient Outcome(s): Required Intervention