MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 ARISTA AH; AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED

Catalog Number	SM0005-USA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.Based on the contents of the article, incorporation of mph hemostatic agents into standard practice may benefit to mitigate ph risk during cied implantations in patients on antithrombotic therapy.Incorporating mph hemostatic agents during cied implantations in such patients may be considered as a valuable addition.The information provided in the article indicates that some patients experienced hematoma complication.The information obtained is limited to the content of the article.The article does not report any specific device malfunction or alleged post-op complications were caused or contributed to the use of the arista ah.Hematoma is known inherent risks of surgery and is listed in the adverse reactions section of the instructions-for-use, supplied with the device as possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (15-dec-2019) is considered to be a best estimate.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
Per journal article: "microporous polysaccharide hemospheres for reducing pocket hematomas after cardiac device implantation in patients on antithrombotic therapy." the article describes a single-center retrospective study aimed to investigate the potential benefits of using (microporous polysaccharide hemospheres) mph hemostatic agents during (cardiac implantable electronic devices) cied implantations as a preventive measure against post-procedural (pocket hematoma) phs.The study conducted with 255 consecutive japanese patients who underwent cied implantation between november 2017 and april 2022.Patients who underwent cied implantation between november 2017 and november 2019 had cied procedures without mph hemostatic agents, while patients from december 2019 to april 2022 had cied procedures with mph hemostatic agents (1g dose of hemostatic agent).The postoperative complications of arista ah include pocket hematoma was observed within 28 days post-operation in 9 patients who received mph hemostatic agents and in 13 patients without mph hemostatic.The article concludes that the findings of this study suggest that the incorporation of mph hemostatic agents into standard practice may benefit to mitigate ph risk during cied implantations in patients on antithrombotic therapy.Incorporating mph hemostatic agents during cied implantations in such patients may be considered as a valuable addition.

• Brand Name: ARISTA AH
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL INC. -1223089; 160 new boston st.; woburn MA 01801
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 22036927
• Report Number: 1213643-2025-00392
• Device Sequence Number: 8160526
• Product Code: LMG
• UDI-Device Identifier: 00801741044120
• UDI-Public: (01)00801741044120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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 Catalogue Number: SM0005-USA
• 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: 04/30/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown