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

Catalog Number	SM0002-USA
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930); Seroma (2069)
Date of Event	04/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per journal article: "effect of microporous polysaccharide hemospheres on anterolateral thigh free flap donor site complications." the aim of the study was to determine if the application of mph (arista ah) during closure of the alt donor site reduces postoperative drain outputs as well as seroma or hematoma formation.This study describes prospective, single-blind, randomized controlled trial of patients undergoing fasciocutaneous alt harvest for head and neck reconstruction at a tertiary academic medical center between april 2018 and february 2020.62 patients were enrolled in the study which includes 34 patients to the intervention group and 28 to the control group.In total, 55 patients were analyzed and noted that 29 patients in the intervention group (mph) and 26 patients in the control group (no-mph).The intervention group received a 3 g dose of mph (arista ah).In mph group, the mean drain output was 284.7 ± 153.0 ml, and the surgical drains were removed after a mean of 5.9 ± 1.5 days.Within 6 months postoperatively, patient had seroma (6), hematoma (2) and donor site infection (2).There was no significant difference in seroma, hematoma, or infection.Drain output was not significantly influenced by gender, age, body weight or smoking habits.The study concluded that the microporous polysaccharide hemospheres administration to anterolateral thigh free flap did not significantly improve drain output, hematoma formation, or seroma formation.
Additional Manufacturer Narrative
Based on the contents of the article, no conclusions can be made.The information provided is limited to the article.The journal article did not include any analysis of how or if the arista ah potentially caused or contributed to any patient outcome or complications.Seroma, hematoma, infection are known inherent risks of the surgery and adverse event as identified in the ifu included with the product.In regards to infection, the warnings section of the ifu states, "arista¿ ah should be used with caution in the presence of infection or in contaminated areas of the body.If signs of infection or abscess develop where arista¿ ah has been applied, re-operation may be necessary in order to allow drainage." no lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (01-apr-2018) is provided as an estimate based on the information provided.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.H3 other text : not returned.

• 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: 18184801
• Report Number: 1213643-2023-00450
• Device Sequence Number: 6466651
• Product Code: LMG
• UDI-Device Identifier: 00801741044106
• UDI-Public: (01)00801741044106
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2023

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: SM0002-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: 10/31/2023
• Initial Report FDA Received Date: 11/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown