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).Information regarding patient date of birth, weight, race, and ethnicity were not provided.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 name, phone and email address of the initial reporter are not available /reported.The device manufacture date is not known as the device lot number is not available /not reported.The event was reported via the (b)(6) study, an (b)(6) female patient with a past medical history of hypertension and dyslipidemia underwent endovascular coil embolization of a 77mm infrarenal abdominal aortic aneurysm (aaa) on an unknown date and experienced a type ii endoleak 178 days following the procedure.Open reintervention was performed as treatment.It is not known whether the type ii endoleak was associated with the target vessel.The study procedure was reintervention of aaa.The initial endovascular aneurysm repair (evar) was performed 402 days prior.The etiology of the aaa was atherosclerosis.Two (2) 3mm x 12cm deltamaxx coils (cdx18031230 /unknown lot number) were 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.It is currently unknown whether the type ii endoleak at 178 days post-procedure was associated with the target vessel embolized with cerenovus coils.Since this condition required reintervention, and the relationship of the coils to the event cannot be excluded at this time, the event meets mdr reporting criteria.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00040.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, an (b)(6) female patient with a past medical history of hypertension and dyslipidemia underwent endovascular coil embolization of a 77mm infrarenal abdominal aortic aneurysm (aaa) on an unknown date and experienced a type ii endoleak 178 days following the procedure.Open reintervention was performed as treatment.It is not known whether the type ii endoleak was associated with the target vessel.The study procedure was reintervention of aaa.The initial endovascular aneurysm repair (evar) was performed 402 days prior.The etiology of the aaa was atherosclerosis.Two (2) 3mm x 12cm deltamaxx coils (cdx18031230 /unknown lot number) were 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 (b)(6) 2022.[additional information]: on (b)(6) 2022, additional information was provided.The information indicated that the reintervention at 178 days post-op was open type reintervention for type ii endoleak via the lumbar artery.E.1: initial reporter phone: 044-544-4611.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00040.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: 13335221
• Report Number: 3008114965-2022-00039
• Device Sequence Number: 5112472
• 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,Study,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: 01/06/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 01/24/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DELTAMAXX CERECYTE 18SYS 3X12
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female