MAUDE Adverse Event Report: SEE H.10 GALAXY G3 MINI 2.5MM X 5.5CM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	GLM925055
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Aneurysm (1708); Infarction, Cerebral (1771); Vasoconstriction (2126); Rupture (2208)
Date of Event	02/28/2019
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, ethnicity, and medical history were not provided.Procode: procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).[conclusion]: the healthcare professional reported that on (b)(6) 2019, during the planned coil embolization that was targeting a ruptured tri-lobed shape aneurysm approximately 2.5 mm in diameter on the left posterior communicating (pcom) artery.The tri-lobed aneurysm had the following dimensions: 4 mm height (cranio-caudal), 5 mm length, and a 2 mm neck.The physician selected a 2.5mm x 5.5cm galaxy g3 mini coil (glm925055 / l13445) to be the first coil.It was reported that access to the aneurysm was slightly challenging due to tortuosity in the proximal vessels, but the aneurysm was itself catharized relatively easily.The aneurysm ruptured following the placement of the coil.A run immediately after the aneurysm catheterization did not show any issues or bleeding.The coil was then deployed, and although there was a slight challenge in feeding the last section of the coil (with the coil being pulled back slightly and then advanced again to help stabilize the microcatheter tip position ¿ with the excelsior®sl-10® microcatheter (stryker) also being advanced forward slightly), it then seemed to sit well within the aneurysm.There was no damage observed on the coil.The microcatheter was noted to move back as the coil was being advanced; as a result, the microcatheter had to be re-positioned.The coil was also partly pulled back and then re-advanced as part of the microcatheter re-positioning.Angiographic imaging undertaken at this point; however, demonstrated extravasation / bleeding from the aneurysm.The coil was therefore detached, and the delivery wire removed.The procedure was completed by using another supplier¿s coils (microvention ¿ 2 x hydrosoft, 1 x hydrofill) to pack the aneurysm fully and stop the bleeding.The patient is thought to have stopped bleeding within approximately 14 mins of this first being noted, as demonstrated by subsequent angiographic imaging.The physician commented that he does not feel the issue was ¿necessarily down to the coil¿ but notes that a loop of coil seems to be feeding into the area where the bleed seems to be emerging from, and this may have been a factor / cause of the bleed.The physician deemed the event itself clinically significant, but not due to delays as the procedure itself was not delayed due to this event.It was reported that the patient was asymptomatic prior to the procedure and made a full recovery and was fine for three days; however, the patient developed vasospasm which led to a left-sided stroke and hemiplegia.Procedure images and medical records were requested but the release of the images and records were denied.Vessel perforation, aneurysm rupture, vasospasm, stroke and neurological deficits are known potential complications of the device and the coil embolization procedure.Cerebral vasospasm is the most common cause of morbidity and mortality in patients after suffering aneurysmal subarachnoid hemorrhage (sah), and delayed cerebral vasospasm usually develops between 4 and 14 days after sah.Based on the information available, it is not possible to determine the root cause of the event; however, the aneurysm had previously been ruptured which would increase the likelihood of a subsequent rupture.The aneurysm shape may have contributed to the positioning difficulty.The coil and the catheter were both within the location of the site of initial bleeding, and both devices had been maneuvered prior to coil detachment (coil pulled back slightly and advanced again with microcatheter also being advanced forward slightly).Therefore, the microcatheter may also have contributed to the event.In addition, the coil was observed to be feeding into the area where the bleed was emerging.This event meets mdr reportability as a serious injury.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (l13445) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation/interaction, aneurysm size/vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported positioning difficulty.Positioning difficulty is a known potential issue associated with the use of the device.With the information available and without the product available for analysis, the reported issue related to positioning difficulty could not be confirmed.In addition, without a lot number to conduct a device history record review, it is not possible to determine if the reported failure could be related to the manufacturing process.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.It is possible that the aneurysm shape and vessel tortuosity may have contributed to the positioning difficulty.The complaint did document that access to the aneurysm was slightly challenging due to tortuosity in the proximal vessels, but the aneurysm was itself catheterized relatively easily.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.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 healthcare professional reported that on (b)(6) 2019, during the planned coil embolization that was targeting a ruptured tri-lobed shape aneurysm approximately 2.5 mm in diameter on the left posterior communicating (pcom) artery.The tri-lobed aneurysm had the following dimensions: 4 mm height (cranio-caudal), 5 mm length, and a 2 mm neck.The physician selected a 2.5mm x 5.5cm galaxy g3 mini coil (glm925055 / l13445) to be the first coil.It was reported that access to the aneurysm was slightly challenging due to tortuosity in the proximal vessels, but the aneurysm was itself catheterized relatively easily.The aneurysm ruptured following the placement of the coil.A run immediately after the aneurysm catheterization did not show any issues or bleeding.The coil was then deployed, and although there was a slight challenge in feeding the last section of the coil (with the coil being pulled back slightly and then advanced again to help stabilize the microcatheter tip position ¿ with the excelsior®sl-10® microcatheter (stryker) also being advanced forward slightly), it then seemed to sit well within the aneurysm.There was no damage observed on the coil.The microcatheter was noted to move back as the coil was being advanced; as a result, the microcatheter had to be re-positioned.The coil was also partly pulled back and then re-advanced as part of the microcatheter re-positioning.Angiographic imaging undertaken at this point; however, demonstrated extravasation / bleeding from the aneurysm.The coil was therefore detached, and the delivery wire removed.The procedure was completed by using another supplier¿s coils (microvention ¿ 2 x hydrosoft, 1 x hydrofill) to pack the aneurysm fully and stop the bleeding.The patient is thought to have stopped bleeding within approximately 14 mins of this first being noted, as demonstrated by subsequent angiographic imaging.The physician commented that he does not feel the issue was ¿necessarily down to the coil¿ but notes that a loop of coil seems to be feeding into the area where the bleed seems to be emerging from, and this may have been a factor / cause of the bleed.The physician deemed the event itself clinically significant, but not due to delays as the procedure itself was not delayed due to this event.It was reported that the patient was asymptomatic prior to the procedure and made a full recovery and was fine for three days; however, the patient developed vasospasm which led to a left-sided stroke and hemiplegia.Procedure images and medical records were requested but the release of the images and records were denied.

• Brand Name: GALAXY G3 MINI 2.5MM X 5.5CM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8449519
• Report Number: 3008114965-2019-00936
• Device Sequence Number: 14184573
• Product Code: KRD
• UDI-Device Identifier: 10886704080282
• UDI-Public: 10886704080282
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

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 Expiration Date: 07/31/2021
• Device Catalogue Number: GLM925055
• Device Lot Number: L13445
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR®SL-10® MICROCATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Other