MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PHASIX ST MESH; SURGICAL MESH

Catalog Number	1200710
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the contents of the article, no conclusions can be made.The information provided in the article indicates that one of the study patient experienced post operative hernia recurrence.The information obtained is limited to the content of the article.The article does not report any specific device malfunction or post-op complications were caused or contributed to the use of the phasix st mesh.Hernia recurrence is listed as a possible complication in the adverse reactions section of the instructions-for-use, provided with the device.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (01-jan-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: "validation of the acs-nsqip surgical risk calculator for patients with paraoesophageal hernias undergoing robotic repair" the objective of this study was to measure the accuracy of this calculator on paraoesophageal hernia (peh) repair.Procedures performed between 2019 and 2023 were retrospectively collected regarding demographics, operative variables, and outcomes with a 30-day follow-up.Thirteen outcomes measured by nsqip-acs calculator were measured.Observed and predicted rates were compared by receiver operating curves (roc) and length of stay was compared by wilcoxon signed rank test.A total of 203 paraoesophageal hernia repairs on patients with a median age of 68 (iqr 61-75) and 70.9% (n = 144) predominantly female.The size of the paraoesophageal hernia (peh) was large or giant in 59.1% (n = 120) and mesh was placed in 70.4% (n = 143).The predicted risk was consistently higher than observed events on all but discharge destinations.Eight outcomes had no event to measure; however, the calculator accurately predicted a risk of less than or equal to 1% on all of these.The area under the curve (auc) was fair (0.6¿0.79) on discharge to nursing or rehabilitation facilities and failed in the rest of the measurable outcomes.All procedures were performed with the da vinci xi surgical system (intuitive surgical inc.) and included hernia sac dissection and reduction, esophageal mobilization, and crural closure with selective reinforcement with biosynthetic resorbable mesh (phasix st (7 x 10 cm) - "u" shaped; cr bard inc., murray hill, nj) based on surgical preference.Postoperative results were 96.6% of patients (n = 195) experienced no complications within 30 days.Only one major complication (0.5%) occurred: an acute gastric volvulus requiring return to the operating room, which was also the one recurrence of hernia recorded within 30 days.Readmission occurred in 2.5% (n = 5) of patients.The current study contributes to the growing body of research supporting the robotic surgical approach in paraoesophageal hernia repair, demonstrating excellent surgical outcomes.The acs-nsqip calculator could benefit from adjustments that account for the nuances of surgical approach.Note: there is no information provided in the article indicating that the device caused or contributed to the postoperative patient complication(s).However, as postoperative complications did present and some requiring medical/surgical intervention we are reporting this as a serious injury mdr.

• Brand Name: PHASIX ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 24341768
• Report Number: 1213643-2026-00140
• Device Sequence Number: 21342370
• Product Code: OWT
• UDI-Device Identifier: 00801741095337
• UDI-Public: (01)00801741095337
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

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: 1200710
• 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: 01/26/2026
• Initial Report FDA Received Date: 02/15/2026
• 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