MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fistula (1862)

Event Date 07/05/2021

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided. Therefore, the patient initials reflect the w. L. Gore internal case number. The date of incident is unknown. Therefore, the online publication date of the literature article is used as date of incident. Review of the manufacturing records could not be performed as a valid lot number was not provided. Engineering evaluation could not be performed as the device was not returned.

Event Description

1 of 2 reports. Other mfg report number: 3013886523-2021-00423. (same valve different failures). A physician reported a certas valve was implanted in a male patient (70-80 years-old) due to inph (idiopathic normal pressure hydrocephalus) via l-p shunt on unknown date with unknown setting. The valve was used with silascon lumbar catheter (manufactured by kaneka, product code: 702-jj). In a (b)(6) 2021, under-drainage occurred. Shunt contrast and image confirmed that the abdominal catheter had deviated, and water had accumulated in the abdomen. It was performed re-placement of abdominal catheter. It is unknown if the patient presented signs and symptoms due to the dysfunction. When the physician checked the certas valve settings the setting, it should have been 7 , but it was 5, the physician tried to change the pressure using etk and it was unsuccessful. When the valve was confirmed inverted by x-ray. The valve was reversed and fixed subcutaneously in the suture hole. The patient's condition was good.

• Brand Name: GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12582690
• MDR Text Key: 274928134
• Report Number: 3003910212-2021-01296
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K030782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/06/2021 Patient Sequence Number: 1