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.[conclusion]: the event was reported via the aaa study, a (b)(6) male patient with a past medical history of dyslipidemia and smoking (previous) underwent endovascular coil embolization of a 54mm infrarenal abdominal aortic aneurysm (aaa) on an unknown date and experienced type ii endoleak 221 days after the procedure requiring reintervention.The patient also had a type ii endoleak of a previously unidentified vessel 161 days post-procedure.The study procedure was reintervention of aaa; the initial endovascular aneurysm repair (evar) was performed 1,993 days prior to this procedure.The etiology of the aaa was atherosclerosis.Two (2) 3mm x 12cm deltamaxx coils (cdx18031230 /unknown lot number) were implanted at the lumbar artery.The coil embolization was deemed successful.There were no procedural complications.The patient was hospitalized ten days.The complaint coils remain implanted and are thus not available for evaluation.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 221 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.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: 3008114965-2022-00035 and.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 aaa study, a (b)(6) male patient with a past medical history of dyslipidemia and smoking (previous) underwent endovascular coil embolization of a 54mm infrarenal abdominal aortic aneurysm (aaa) on an unknown date and experienced type ii endoleak 221 days after the procedure requiring reintervention.The patient also had a type ii endoleak of a previously unidentified vessel 161 days post-procedure.The study procedure was reintervention of aaa; the initial endovascular aneurysm repair (evar) was performed 1,993 days prior to this procedure.The etiology of the aaa was atherosclerosis.Two (2) 3mm x 12cm deltamaxx coils (cdx18031230 /unknown lot number) were implanted at the lumbar artery.The coil embolization was deemed successful.There were no procedural complications.The patient was hospitalized ten days.The complaint coils remain implanted and are thus not available for evaluation.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 28-jan-2022.The event was reported via the (b)(6) study, a 69-year-old male patient with a past medical history of dyslipidemia and smoking (previous) underwent endovascular coil embolization of a 54mm infrarenal abdominal aortic aneurysm (aaa) on an unknown date and experienced type ii endoleak 221 days after the procedure requiring reintervention.The patient also had a type ii endoleak of a previously unidentified vessel 161 days post-procedure.The study procedure was reintervention of (b)(6); the initial endovascular aneurysm repair (evar) was performed 1,993 days prior to this procedure.The etiology of the (b)(6) was atherosclerosis.Two (2) 3mm x 12cm deltamaxx coils (cdx18031230 / unknown lot number) were implanted at the lumbar artery.The coil embolization was deemed successful.There were no procedural complications.The patient was hospitalized ten days.The complaint coils remain implanted and are thus not available for evaluation.[additional information]: the target vessel of the registered coiling procedure was the left lumbar artery.The target vessel of the reintervention was the right lumbar artery identified on imaging study after the coiling procedure.Per the additional information received on 28-jan-2022, the reintervention was performed 221 days post-procedure at the right lumbar artery; the vessel that was embolized with coils was the left lumbar artery.There is no medical evidence to suggest that the type ii endoleak of the non-target vessel was related to the cerenovus coils.Thus, the event no longer meets mdr reporting criteria.No further reports will be forthcoming.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00035 and 3008114965-2022-00036.

• 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: 13388733
• Report Number: 3008114965-2022-00036
• Device Sequence Number: 14686257
• 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): 01/28/2022

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: 01/28/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 01/31/2022
• 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: 69 YR
• Patient Sex: Male