MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 3MM X 12CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The initial reporter phone: (b)(6).The initial reporter email address is not available / reported.[conclusion]: the healthcare professional reported that a patient underwent a coil embolization of a hemorrhagic monumental aneurysm on an unknown date.Transarterial embolization (tae) was performed for posterior gastric artery hemorrhage.The right common femoral artery was punctured.A 5f sheath was inserted into the celiac artery.Contrast imaging showed a developed and tortuous posterior gastric artery.No obvious extravasation was observed.No monumental trunk was found, and anastomotic branches with the gastroepiploic artery were developed.A balloon was used to insert the headway microcatheter (microvention) into the posterior gastric artery while balloon occlusion was performed at the origin of the celiac artery.However, but the microcatheter could not follow the headway.Therefore, the parent catheter was replaced with another one (4f) and it was advanced to the proximal side of the posterior gastric artery.The microcatheter was replaced with a veloute (asahi intecc) microcatheter and the catheter was inserted beyond the tortuous portion to the anastomosis with the monumental artery.First, coiling was attempted with a 4mm x 8cm target xl coil (stryker), but the coil was not stable and became unraveled during position adjustment.The coil was placed on the side of the monumental site beyond the tortuous part.Based on the prior computed tomography (ct) scan, coiling was performed using two 3mm x 8cm target xl coils, followed by a 3mm x 12cm deltafill18 coil (dlf180312 / l11823 or l11279) in the area where the posterior gastric artery is considered to exceed the gastric intramural portion.From the more proximal side, the tortuous portion was embolized with a total of 0.6cc of n-butyl cyanoacrylate (n-bca) with 25% n-bca lipiodol.Imaging from the proximal posterior gastric artery revealed collateral circulation from the proximal n-bca to the gastric wall and spleen.A ct was taken and compared with the contrast-enhanced ct performed at the previous hospital, it was judged that the bleeding point was sufficiently embolized, although the posterior gastric artery in the gastric wall slightly remained in the proximal side.As disappearance of the tortuous part of the posterior gastric artery was confirmed on imaging, the sheath was removed, hemostasis was achieved with manual pressure, and the procedure was completed.Blood flow to the spleen may be maintained at about 40 ~ 50% of the preoperative level.The company sales representative received an update from the physician that the target competitor coil or the deltafill19 complaint coil was observed to be coming out of the stomach.Imaging has been provided.In this case, the target competitor coil was used in addition to the complaint coil.Therefore, it is unknown which coil has entered the stomach.The physician is considering cutting the coil endoscopically.Additional information was received on 03-feb-2022.The information confirmed that the procedure date was (b)(6) 2019.The event was discovered by endoscopy at the follow-up visit; it is not known how long after the procedure that the event was discovered.There was no device performance issue or malfunction reported.The lot number of the coil was not determined; the lot number was either l11823 or l11279.The complaint device is not available for evaluation.However, medical imaging was provided.Returned medical imaging was reviewed by cerenovus medical safety officer (mso) on 04-feb-2022.The assessment reads as follows: "the procedure describes the embolization of the posterior gastric artery with the use of a combination of embolic coils and nbca liquid embolic.As per the provided case description, the coils (including complaint and noncompliant coils) and nbca performed as intended with desired placement achieved.There was acceptable embolization of the posterior gastric artery as confirmed by angiography and subsequent ct on the day of the procedure.On january 24, 2022, chu was alerted that the patient had undergone a subsequent endoscopy and three endoscopic images were provided.The exact time frame between the use of the complaint device in the embolization of the posterior gastric artery and the subsequent endoscopy is not provided.It is presumed the endoscopy was recently performed and therefore at a several year time span from the primary embolization procedure.In addition, any patient health concerns that prompted the endoscopy are not provided.Three images are provided from an upper endoscopy which are stated to be from the stomach portion of the gi tract.Endoscopic images demonstrate a single point of exit from the stomach mucosa of two curvilinear metallic appearing wires which may be ends of a single metallic wire or two separate wires exiting the gastric mucosa and entering the stomach lumen.Both wires appear to have similar caliber and characteristic making the origin of both likely from a single source.In addition, one image demonstrates a translucent band of material extending across a portion of one wire with a t shaped extension to another segment of the gastric mucosa.This band likely represents an adhesion.Based solely on the images it is not possible to determine the origin of the metallic appearing wires.Correlation with additional imaging studies such as a ct scan and information of exact location of wires in the stomach on the endoscopy would be helpful.If there is no other significant history of use of surgical devices in the stomach, and the endoscopic images are in the region supplied by the posterior gastric artery, it is reasonable to assume these wires represent embolic coils from the previously performed posterior gastric artery embolization.From the images it is impossible to determine if these wires represent the complaint coil or noncompliant coils.Intravascular surgical devices have been known to erode from their point of deployment through the vascular wall and into surrounding structures (i.E., ivc filter erosion through the ivc vessel wall).No conclusions regarding the root cause of this event can be determined based on the information currently available." physician name and date reviewed: (b)(6) md, february 4, 2022.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (l11823) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The manufacture date of this lot is 23-mar-2018 / the associated expiration date is 28-feb-2021.A review of manufacturing documentation associated with this lot (l11279) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The manufacture date of this lot is 23-jan-2018 / the associated expiration date is 31-dec-2020.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 is a known potential complication associated with the use of the deltafill18 coil in coil embolization procedures.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 was no report of any coil malfunction or intraoperative complication.Since the vessel perforation required surgical intervention to preclude further injury, and the relationship of the device to the reported event cannot be disassociated, it is considered serious and mdr reportable.Based on the manufacturing documentation reviews, there is no indication that the event is related to the device manufacturing process.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.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that a patient underwent a coil embolization of a hemorrhagic monumental aneurysm on an unknown date.Transarterial embolization (tae) was performed for posterior gastric artery hemorrhage.The right common femoral artery was punctured.A 5f sheath was inserted into the celiac artery.Contrast imaging showed a developed and tortuous posterior gastric artery.No obvious extravasation was observed.No monumental trunk was found, and anastomotic branches with the gastroepiploic artery were developed.A balloon was used to insert the headway microcatheter (microvention) into the posterior gastric artery while balloon occlusion was performed at the origin of the celiac artery.However, but the microcatheter could not follow the headway.Therefore, the parent catheter was replaced with another one (4f) and it was advanced to the proximal side of the posterior gastric artery.The microcatheter was replaced with a veloute (asahi intecc) microcatheter and the catheter was inserted beyond the tortuous portion to the anastomosis with the monumental artery.First, coiling was attempted with a 4mm x 8cm target xl coil (stryker), but the coil was not stable and became unraveled during position adjustment.The coil was placed on the side of the monumental site beyond the tortuous part.Based on the prior computed tomography (ct) scan, coiling was performed using two 3mm x 8cm target xl coils, followed by a 3mm x 12cm deltafill18 coil (dlf180312 / l11823 or l11279) in the area where the posterior gastric artery is considered to exceed the gastric intramural portion.From the more proximal side, the tortuous portion was embolized with a total of 0.6cc of n-butyl cyanoacrylate (n-bca) with 25% n-bca lipiodol.Imaging from the proximal posterior gastric artery revealed collateral circulation from the proximal n-bca to the gastric wall and spleen.A ct was taken and compared with the contrast-enhanced ct performed at the previous hospital, it was judged that the bleeding point was sufficiently embolized, although the posterior gastric artery in the gastric wall slightly remained in the proximal side.As disappearance of the tortuous part of the posterior gastric artery was confirmed on imaging, the sheath was removed, hemostasis was achieved with manual pressure, and the procedure was completed.Blood flow to the spleen may be maintained at about 40 ~ 50% of the preoperative level.The company sales representative received an update from the physician that the target competitor coil or the deltafill19 complaint coil was observed to be coming out of the stomach.Imaging has been provided.In this case, the target competitor coil was used in addition to the complaint coil.Therefore, it is unknown which coil has entered the stomach.The physician is considering cutting the coil endoscopically.Additional information was received on 03-feb-2022.The information confirmed that the procedure date was (b)(6) 2019.The event was discovered by endoscopy at the follow-up visit; it is not known how long after the procedure that the event was discovered.There was no device performance issue or malfunction reported.The lot number of the coil was not determined; the lot number was either l11823 or l11279.The complaint device is not available for evaluation.However, medical imaging was provided.Returned medical imaging was reviewed by cerenovus medical safety officer (mso) on 04-feb-2022.The assessment reads as follows: "the procedure describes the embolization of the posterior gastric artery with the use of a combination of embolic coils and nbca liquid embolic.As per the provided case description, the coils (including complaint and noncompliant coils) and nbca performed as intended with desired placement achieved.There was acceptable embolization of the posterior gastric artery as confirmed by angiography and subsequent ct on the day of the procedure.On january 24, 2022, chu was alerted that the patient had undergone a subsequent endoscopy and three endoscopic images were provided.The exact time frame between the use of the complaint device in the embolization of the posterior gastric artery and the subsequent endoscopy is not provided.It is presumed the endoscopy was recently performed and therefore at a several year time span from the primary embolization procedure.In addition, any patient health concerns that prompted the endoscopy are not provided.Three images are provided from an upper endoscopy which are stated to be from the stomach portion of the gi tract.Endoscopic images demonstrate a single point of exit from the stomach mucosa of two curvilinear metallic appearing wires which may be ends of a single metallic wire or two separate wires exiting the gastric mucosa and entering the stomach lumen.Both wires appear to have similar caliber and characteristic making the origin of both likely from a single source.In addition, one image demonstrates a translucent band of material extending across a portion of one wire with a t shaped extension to another segment of the gastric mucosa.This band likely represents an adhesion.Based solely on the images it is not possible to determine the origin of the metallic appearing wires.Correlation with additional imaging studies such as a ct scan and information of exact location of wires in the stomach on the endoscopy would be helpful.If there is no other significant history of use of surgical devices in the stomach, and the endoscopic images are in the region supplied by the posterior gastric artery, it is reasonable to assume these wires represent embolic coils from the previously performed posterior gastric artery embolization.From the images it is impossible to determine if these wires represent the complaint coil or noncompliant coils.Intravascular surgical devices have been known to erode from their point of deployment through the vascular wall and into surrounding structures (i.E., ivc filter erosion through the ivc vessel wall).No conclusions regarding the root cause of this event can be determined based on the information currently available." physician name and date reviewed: (b)(6) md, february 4, 2022.

• Brand Name: DELTAFILL18 3MM X 12CM
• 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: 13483058
• Report Number: 3008114965-2022-00069
• Device Sequence Number: 17502179
• Product Code: KRD
• UDI-Device Identifier: 10886704077190
• UDI-Public: 10886704077190
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2022

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: DLF180312
• Device Catalogue Number: DLF180312
• 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: 01/23/2022
• Initial Report FDA Received Date: 02/08/2022
• 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: 4F NISHIYA SHEATH INTRODUCER; 5F/45CM J-TYPE SHEATH; ENPOWER DCB 2; SELECON BALLOON CATHETER (TERUMO)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown