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 Interaction Problem (4001)
Health Effect - Clinical Codes	Airway Obstruction (1699); Edema (1820); Swelling (2091)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient developed angioedema of the tongue after the use of arista ah.The surgeon reports that she considers a reaction to arista ah to be unlikely in this case, and identified the response was possibly expected due to other medications the patient was taking for hypertension.However, based on the information provided we are unable to determine to what extent, if any, the arista ah may have caused or contributed to the alleged postoperative complications.No lot number has been provided, therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.Sample not available.
Event or Problem Description
It was reported that, on (b)(6) 2020, the patient experienced brisk bleeding during a zenker¿s diverticulum (esophageal diverticulum) case and a 3g arista ah was used and hemostasis was achieved.The surgeon could not use irrigation around the implant, but used suction to remove the residual material.The patient was released and later experienced post-op swelling of the tongue a few hours after surgery.The patient required treatment at an er and was intubated, after which, the patient was reported to be recovering and doing well.Doctor identified that the patient was on lisinopril and blood pressure medication and stated that the patient is a long-time user and has not experienced any similar events and considered a reaction to arista ah to be unlikely in this case.The identified response was possibly expected due to other medications the patient was taking for hypertension.

• 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
• MDR Report Key: 10710814
• Report Number: 1213643-2020-20019
• Device Sequence Number: 3058814
• Product Code: LMG
• UDI-Device Identifier: 00801741044106
• UDI-Public: (01)00801741044106
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P050038
• 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
• Report Date (Section B): 10/06/2020

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/21/2020
• 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: Required Intervention