MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAMAXX CERECYTE 18SYS 4X15; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	CDX180415-30
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
Event or Problem Description
The event was reported via the aaa study, a (b)(6) female patient with a past medical history of hypertension, diabetes, cerebrovascular disease, and dyslipidemia underwent endovascular coil embolization of an infrarenal 46mm abdominal aortic aneurysm (aaa) and experienced type ii target vessel endoleaks at days 81 and 179.The procedure was an initial abdominal endovascular aneurysm repair (evar).The etiology of the aaa was atherosclerosis.Stent graft used was a gore excluder leg.A total of two spectra (cerenovus) coils were implanted at the inferior mesenteric artery (ima): one 4mm x 15cm deltamaxx (cdx18041530 / lot# unknown) and one 5mm x 20cm deltamaxx (cdx18052030 / lot# unknown).Fluoroscopy time was 157 minutes.The coil embolization was deemed successful.The patient was hospitalized ten days.
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/study 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 and email address of the initial reporter are not available / reported.The initial reporter phone: (b)(6).Initial reporter address line 1: (b)(6).The device manufacture date is not known as the device lot number is not available / not reported.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.Since this condition may require additional intervention or retreatment or can be reasonably expected to result in medical or surgical intervention, including hospitalization, and the relationship of the coils to the event cannot be excluded.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: 3008114965-2021-00761.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.
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/study 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 and email address of the initial reporter are not available / reported.The initial reporter phone: (b)(6).Initial reporter address line 1: (b)(6).The device manufacture date is not known as the device lot number is not available / not reported.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.Since this condition may require additional intervention or retreatment or can be reasonably expected to result in medical or surgical intervention, including hospitalization, and the relationship of the coils to the event cannot be excluded.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: 3008114965-2021-00761.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) female patient with a past medical history of hypertension, diabetes, cerebrovascular disease, and dyslipidemia underwent endovascular coil embolization of an infrarenal 46mm abdominal aortic aneurysm (aaa) and experienced type ii target vessel endoleaks at days 81 and 179.The procedure was an initial abdominal endovascular aneurysm repair (evar).The etiology of the aaa was atherosclerosis.Stent graft used was a gore excluder leg.A total of two spectra (cerenovus) coils were implanted at the inferior mesenteric artery (ima): one 4mm x 15cm deltamaxx (cdx18041530 / lot# unknown) and one 5mm x 20cm deltamaxx (cdx18052030 / lot# unknown).Fluoroscopy time was 157 minutes.The coil embolization was deemed successful.The patient was hospitalized ten days.

• Brand Name: DELTAMAXX CERECYTE 18SYS 4X15
• 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: 13080211
• Report Number: 3008114965-2021-00760
• Device Sequence Number: 19872086
• Product Code: KRD
• UDI-Device Identifier: 10878528008559
• UDI-Public: 10878528008559
• 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
• Report Date (Section B): 12/23/2021

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: CDX180415-30
• Device Catalogue Number: CDX18041530
• 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: 12/15/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTAMAXX CERECYTE 18SYS 5X20
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female