MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAMAXX CERECYTE 18SYS 3X12; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	CDX180312-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Date of event: the date of the event is not known.Procode is krd/hcg.The expiration date of the device is not known as the device lot number is not available / not reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the event was reported via the (b)(6) study, a (b)(6) year-old male patient with a past medical history of hypertension, coronary artery disease (cad), dyslipidemia, renal insufficiency, and smoking (previous) underwent endovascular coil embolization of a 63mm infrarenal abdominal aortic aneurysm (aaa) on an unknown date and experienced a type ii endoleak of the lumbar artery 110 days following the procedure.Endovascular reintervention was performed as treatment.The patient then underwent endovascular reintervention of a type ib endoleak 113 days post-procedure.The study procedure was reintervention of aaa.The initial endovascular aneurysm repair (evar) was performed 1,864 days prior.The etiology of the aaa was atherosclerosis.One (1) cerenovus coil, a 3mm x 12cm deltamaxx coils (cdx18031230 / unknown lot number) was implanted at the lumbar artery.Coil embolization was considered successful.There were no reported procedural complications.Based on complaint information, the device remains implanted and is thus not available for evaluation.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.The type ii endoleak at 110 days post-procedure was associated with the lumbar artery; the cerenovus coil was implanted at the lumbar artery.Since this condition required endovascular reintervention, and the relationship of the coil to the event cannot be excluded at this time.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 or Problem Description
The event was reported via the (b)(6) study, a (b)(6) year-old male patient with a past medical history of hypertension, coronary artery disease (cad), dyslipidemia, renal insufficiency, and smoking (previous) underwent endovascular coil embolization of a 63mm infrarenal abdominal aortic aneurysm (aaa) on an unknown date and experienced a type ii endoleak of the lumbar artery 110 days following the procedure.Endovascular reintervention was performed as treatment.The patient then underwent endovascular reintervention of a type ib endoleak 113 days post-procedure.The study procedure was reintervention of aaa.The initial endovascular aneurysm repair (evar) was performed 1,864 days prior.The etiology of the aaa was atherosclerosis.One (1) cerenovus coil, a 3mm x 12cm deltamaxx coils (cdx18031230 / unknown lot number) was implanted at the lumbar artery.Coil embolization was considered successful.There were no reported procedural complications.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 09-feb-2022.[additional information]: on 09-feb-2022, additional information was provided.The information is only pertaining to the initial reporter.The physician¿s name is not known.E.1: initial reporter phone: (b)(6).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: DELTAMAXX CERECYTE 18SYS 3X12
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-8687
• MDR Report Key: 13388938
• Report Number: 3008114965-2022-00041
• Device Sequence Number: 4998952
• Product Code: KRD
• UDI-Device Identifier: 10878528008542
• UDI-Public: 10878528008542
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CDX180312-30
• Device Catalogue Number: CDX18031230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male