MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC TRUFILL N-BCA-1 GRAM KIT; TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS

Catalog Number	631500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Infarction, Cerebral (1771); Embolism (1829)
Date of Event	12/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Lot: the reported product lot number (hn1042) is the glue sub-assembly of the trufill n-bca-1 gram kit.The lot number of the kit that was used in the case is currently unknown.The potential lot numbers are hr1780 and hp6250.The manufacturing and quality records will be reviewed for both lots as applicable per our internal procedure.These records will comprise our lots/batches history records, which were created during the manufacturing of the device.The product is not available for evaluation and testing.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, a (b)(6) year-old male patient with an unreported medical history underwent a left middle cerebral artery embolization using nbca glue (631500/hr1780 or hp6250) and 8 hours later developed a subsequent ischemic stroke from the embolic material.The pathology report confirmed that the embolic material captured in thrombectomy was black pigmented and suggestive of nbca.It was reported that the product was discarded.No further information was provided.
Additional Manufacturer Narrative
Product complaint(b)(4).As reported by a healthcare professional, a 62-year-old male patient with an unreported medical history underwent a left middle cerebral artery embolization using trufill n-bca glue (631500/ hr1780 or hp6250) and 8 hours later developed a subsequent ischemic stroke from the embolic material.The pathology report confirmed that the embolic material captured in thrombectomy was black pigmented and suggestive of nbca.Multiple attempts to obtain additional information were unsuccessful.The trufill n-bca-1 gram kit was not returned for evaluation.The lot number of the kit was not reported; however, two potential lot numbers were associated with the reported glue subassembly hn1042 (hr1780 & hp6250).A review of the manufacturing documentation associated with these potential lots presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Trufill n-bca liquid embolic system is indicated for the embolization of cerebral arteriovenous (av) malformations when pre-surgical devascularization is desired.Passage of embolic material into normal vessels adjacent to the lesion and stroke are known events associated with embolization procedures and are listed in the instructions for use (ifu) as such.The root cause of the embolized nbca and ischemic stroke cannot be determined based on the minimal information provided.The indication for the embolization was not specified and it was not indicated if the nbca was used in an area of high blood flow.There is no evidence that suggests that the reported adverse event was related to the device manufacturing process.With the amount of information available and without films of the event, it is not possible to draw a clinical conclusion between the device and the reported event.However, patient and procedural factors may have contributed to the reported event.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.

• Brand Name: TRUFILL N-BCA-1 GRAM KIT
• Common Device Name: TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8219405
• Report Number: 1226348-2019-00815
• Device Sequence Number: 202432
• Product Code: KGG
• UDI-Device Identifier: 10886704029151
• UDI-Public: 10886704029151
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P990040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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: 02/29/2020
• Device Catalogue Number: 631500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR