MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SYNETURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	VLOCN0346
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, post-operative a cruroplasty fundoplication performed last april, the patient was re-admitted into the hospital because the patient had a narrowing of the esophagus and scar tissue formation around the suture.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, post-operative a crucoplasty fundoplication performed last april, the patient was re-admitted into the hospital because the patient had a narrowing of the esophagus and scar tissue formation around the suture.Six weeks ago, the patient underwent a procedure to place an esophageal stent for dilation.The patient was subsequently released from the hospital and was stable.

• Brand Name: SYNETURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20274626
• Report Number: 1219930-2024-04425
• Device Sequence Number: 3469961
• Product Code: GAT
• UDI-Device Identifier: 10884521762527
• UDI-Public: 10884521762527
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K103052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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 Model Number: VLOCN0346
• Device Catalogue Number: VLOCN0346
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/28/2024
• 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: Other; Hospitalization
• Patient Sex: Male