MAUDE Adverse Event Report: ETHICON INC. TVT EXACT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number TVTRL

Device Problem Break (1069)

Patient Problems Nausea (1970); Pain (1994); Injury (2348); Device Embedded In Tissue or Plaque (3165); Not Applicable (3189); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria for lot 3933436 and product code tvtrl.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported that three inches of the silicone that covers the mesh was retained in the patient.Please clarify when it says that the silicone that covers the mesh was retained are you actually saying that the clear plastic implant sheath that covers the mesh and is held between two white trocar sheaths, which are bonded to the implant and implant sheath was left inside the patient (verbiage for information for use)? the mesh was implanted and then the surgeon decided to remove the mesh.Please indicate why after placing the mesh did the surgeon decide to remove the mesh? was there something wrong with the product/mesh that the surgeon removed it after implanting it? per the ifu under instructions for use: the implant is cut bilaterally close to the connection to the trocar sheaths.The implant sheaths that surround the implant are grasped with clamps and removed.Did the surgeon successfully place the mesh and cut the mesh and clear plastic implant sheath close to the connection of the white trocar sheath in order to remove the clear plastic sheath or did the mesh and or sheath prematurely detach from the white trocar sheath? confirm that the clear plastic implant sheath that covers the mesh remains in the patient? has the patient reported any adverse experiences as a result of the clear plastic sheath remaining in the patient¿s cavity? as a result of the clear plastic sheath remaining in the patient did the surgeon provide any medical treatment or surgical intervention as a result of the sheath being retained in the patient? how was the procedure completed? provide patient demographics which include: patient¿s name or initials.Date of birth & age time of surgical procedure.Patient¿s medical history.

Event Description

It was reported that the patient underwent an unknown gynecological procedure on (b)(6) 2019 and the mesh was implanted.A doctor placed the mesh in the patient, decided to remove the mesh and lost three inches of the silicone that covers the mesh within the mesh tracking inside the patient.A doctor attempted to remove the silicone but was not able to remove a product.Additional information has been requested.

Manufacturer Narrative

Date sent to fda: 10/13/2020.H6 patient codes: 3189- surgical intervention.Additional b5 narrative: it was reported that the patient underwent removal surgery, exploration of the abdominal wall, placement of a wound vac, cystoscopy sheath removal, wound vac removal, and penrose drain placement, on (b)(6) 2019.

Manufacturer Narrative

Date sent to the fda:11/26/2020.Additional b5 narrative: it was reported that perforation in the patient's bladder was found.It was reported that the patient experienced pain in her lower right quadrant of her abdomen, back pain extending into the lower extremities, nausea, cramps in back and right lower quadrant and pain in pubic area.

Manufacturer Narrative

Date sent to the fda: 4/21/2022.

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082183429
• MDR Report Key: 8836568
• MDR Text Key: 152533166
• Report Number: 2210968-2019-84729
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3933436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female