MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 22MM X 60CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number DLF182260

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

Patient Problem Perforation of Vessels (2135)

Event Type  Injury  

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 initial reporter name and email address 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.[conclusion]: the event was reported via the aaa study, a (b)(6) male patient with a past medical history of hypertension, diabetes, coronary artery disease, cerebrovascular disease, dyslipidemia, and smoking (previous) underwent endovascular coil embolization of an infrarenal 55mm abdominal aortic aneurysm (aaa) and experienced a vessel dissection or perforation during the procedure.The procedure was an initial abdominal endovascular aneurysm repair (evar).The etiology of the aaa was atherosclerosis.Stent graft used was a gore excluder aaa-endoprosthesis.A total of four spectra (cerenovus) coils were implanted at the internal iliac artery (iia): one 20mm x 60cm deltafill18 (dlf182060 / lot# unknown), one 22mm x 60cm deltafill18 (dlf182260 / lot# unknown), one 18mm x 55cm deltafill18 (dlf181855 / lot# unknown), and one 10mm x 40cm deltafill18 (dlf181040 / lot# unknown).Fluoroscopy time was 57 minutes.The coil embolization was deemed successful.The patient was hospitalized ten days.The coils are not available for evaluation.No further information was provided.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.Vessel perforation or dissection is a known potential adverse event associated with coil embolization procedures and is listed in the spectra coil instructions for use (ifu) as such.With the information provided, the root cause of the event cannot be determined.However, there are patient and procedural factors that may have contributed to the reported event.There is no indication that the coils malfunctioned or that it is related to the device design or manufacturing process.Since the severity of the event is unknown 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 4 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00756, 3008114965-2021-00758, and 3008114965-2021-00759.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information will be submitted within 30 days of receipt.

Event Description

The event was reported via the aaa study, a (b)(6) male patient with a past medical history of hypertension, diabetes, coronary artery disease, cerebrovascular disease, dyslipidemia, and smoking (previous) underwent endovascular coil embolization of an infrarenal 55mm abdominal aortic aneurysm (aaa) and experienced a vessel dissection or perforation during the procedure.The procedure was an initial abdominal endovascular aneurysm repair (evar).The etiology of the aaa was atherosclerosis.Stent graft used was a gore excluder aaa-endoprosthesis.A total of four spectra (cerenovus) coils were implanted at the internal iliac artery (iia): one 20mm x 60cm deltafill18 (dlf182060 / lot# unknown), one 22mm x 60cm deltafill18 (dlf182260 / lot# unknown), one 18mm x 55cm deltafill18 (dlf181855 / lot# unknown), and one 10mm x 40cm deltafill18 (dlf181040 / lot# unknown).Fluoroscopy time was 57 minutes.The coil embolization was deemed successful.The patient was hospitalized ten days.The coils are not available for evaluation.No further information was provided.

• Brand Name: DELTAFILL18 22MM X 60CM
• Type of Device: 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 ; 949789-868
• MDR Report Key: 13112382
• MDR Text Key: 288315813
• Report Number: 3008114965-2021-00757
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077176
• UDI-Public: 10886704077176
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DLF182260
• Device Catalogue Number: DLF182260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELTAFILL18 10MM X 40CM; DELTAFILL18 18MM X 55CM; DELTAFILL18 20MM X 60CM
• Patient Outcome(s): Life Threatening
• Patient Age: 79 YR
• Patient Sex: Male