MAUDE Adverse Event Report: ADVANT MEDICAL

Lot Number 19D099AV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage, Subarachnoid (1893); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.Patient codes: the fda code: no code available fda (b)(4) was chosen to capture the surgical intervention in the use of emergent coil embolization.[conclusion]: the healthcare professional reported that the 5 x 33mm embotrap ii revascularization device (et009533 / 19d099av) was used during a mechanical thrombectomy procedure to treat an acute ischemic stroke, as the thrombus was being removed, the patient¿s blood vessel was injured.The patient developed a subarachnoid hemorrhage (sah) which required emergent coil embolization.The current status of the patient is not known.The physician commented that ¿the event might have caused by the patient¿s blood vessel whose atherosclerosis had developed and the wall had been damaged, therefore, not only the complaint device but also other stent retriever might have brought similar cases if they used.¿ based on complaint information, the device was not available to be returned for analysis.A review of the device history record (dhr) associated with this lot (19d099av) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.There was no report of any device malfunction.As such, the investigation will be closed.Vascular injury and hemorrhage are well-known extensively documented potential complications associated with endovascular mechanical thrombectomy for acute ischemic stroke cases and are listed in the embotrap instructions for use (ifu) as such.The root cause of the event cannot be determined without procedural films; however, clinical and procedural factors including vessel characteristics, tortuosity, device selection, and mechanical manipulation of devices within the artery are all factors that may contribute to vascular injury or perforation.There was no report of a device malfunction or performance issue associated with the event.The reporting physician also stated that the patient had pre-existing atherosclerosis.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 of failure to detach was related to a manufacturing or design issue, no corrective actions will be taken at this time.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 that the 5 x 33mm embotrap ii revascularization device (et009533 / 19d099av) was used during a mechanical thrombectomy procedure to treat an acute ischemic stroke, as the thrombus was being removed, the patient¿s blood vessel was injured.The patient developed a subarachnoid hemorrhage (sah) which required emergent coil embolization.The current status of the patient is not known.The physician commented that ¿the event might have caused by the patient¿s blood vessel whose atherosclerosis had developed and the wall had been damaged, therefore, not only the complaint device but also other stent retriever might have brought similar cases if they used.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the device lot number that was inadvertently not included in the initial report and to document that the event date including day, month, and year were not reported.Updated to include the device lot number.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 is to include the additional event information received on 3/5/2020.Initial reporter phone: (b)(6).The initial reporter email address is not available / reported.Updated sections: 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 (Section G): ADVANT MEDICAL; parkmore business park west; galway H91 P V0V; EI H91 PV0V
• MDR Report Key: 9688040
• MDR Text Key: 182920497
• Report Number: 3011370111-2020-00014
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 19D099AV
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention