MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5992025
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The preliminary sample evaluation confirms the suture strut of the frame has torn off and detachment of one of the mesh connectors.As reported the user was removing the frame from the correct location.Visual examination confirms the tear in the material as reported.This appears to be related to forces applied to the device.However a definitive cause of the problem cannot be established at this time.
Event or Problem Description
It was reported that during a ventral hernia repair case performed on (b)(6) 2019 the ventralight st w/ echo 2 ps mesh was placed in the abdomen and fastened into place using the capsure and optifix at fixation devices.The surgeon began to pull on the frame for removal and is reported to have pulled to the very right of the area on the frame that says "remove".As the surgeon was removing the frame the arm broke off and he noted a blue coil (connector) to be laying in the abdominal space, by itself, free from the frame.The surgeon continued to remove the frame and the detached pieces.There were no loose pieces of the frame left in the patient and no additional interventions had to be taken to remove the pieces.The mesh remained implanted in the abdomen.This was the surgeons first time using the echo 2 ps device.The surgeon does have experience with the echo 1 ps device.As reported there was no injury to the patient.
Event or Problem Description
It was reported that during a ventral hernia repair case performed on (b)(6) 2019 the ventralight st w/ echo 2 ps mesh was placed in the abdomen and fastened into place using the capsure and optifix at fixation devices.The surgeon began to pull on the frame for removal and is reported to have pulled to the very right of the area on the frame that says "remove".As the surgeon was removing the frame the arm broke off and he noted a blue coil (connector) to be laying in the abdominal space, by itself, free from the frame.The surgeon continued to remove the frame and the detached pieces.There were no loose pieces of the frame left in the patient and no additional interventions had to be taken to remove the pieces.The mesh remained implanted in the abdomen.This was the surgeons first time using the echo 2 ps device.The surgeon does have experience with the echo 1 ps device.As reported there was no injury to the patient.
Additional Manufacturer Narrative
The preliminary sample evaluation confirms the suture strut of the frame has torn off and detachment of one of the mesh connectors.As reported the user was removing the frame from the correct location.Visual examination confirms the tear in the material as reported.This appears to be related to forces applied to the device.However a definitive cause of the problem cannot be established at this time.This is an addendum to the initial emdr to document the results of the sample evaluation.The sample evaluation confirms the suture strut of the frame has torn off and detachment of one of the mesh connectors.Examination identifies the tear in the material traveled into the portion of the frame that retains one of the mesh connectors.This resulted in the mesh connector detaching.Based on the event as reported and product evaluation the tear of the frame is related to the forces applied during user/device interface.Evaluation identifies no manufacturing anomalies.Based on the condition of the device it is possible the user did not unclamp and cut the center suture during removal or pulled from the strut.To date this is the only reported complaint for this production lot of 115 units released for distribution in (b)(6) 2019.Regarding the removal of the device the instructions-for-use state: removal of echo 2¿ positioning system frame 1.Remove the atraumatic clamp or hemostat from the hoisting suture and, external to the patient, cut the center hoisting suture close to the patient¿s skin.2.Begin removal of the echo 2¿ positioning system frame by grasping one of the designated points indicated by the ¿remove¿ symbol or anywhere along the green removal indicator line on the frame.Removing from any other location is not recommended.Begin pulling the positioning system off the mesh in one smooth motion.The connectors that attach the frame to the mesh will detach one-by-one from the mesh.Maintain constant visualization and ensure no tissue or organs are caught while removing the frame through the trocar.Never remove the device from the center frame struts.Note: the echo 2¿ positioning system frame is designed to separate into one strand when removed.It is recommended that the frame is removed from the same size trocar from which it was inserted.3.Continue to remove the echo 2¿ positioning system frame by pulling it through the trocar and out of the abdomen.4.Verify that the echo 2¿ positioning system frame is fully intact after removal, including all components listed in table 2 and discard appropriately.Updated fields: b4, g4, g7, h2, h6, h10 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.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9516695
• Report Number: 1213643-2019-12501
• Device Sequence Number: 19257263
• Product Code: FTL
• UDI-Device Identifier: 00801741131042
• UDI-Public: (01)00801741131042
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2020
• Device Catalogue Number: 5992025
• Device Lot Number: HUDS1615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1