MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD PTFE POLYMER PLEDGETS; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	VPG36SE
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Inflammation (1932); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the survey performed which covers the last 12 months for the adverse event reaction using the suture, one mild to moderate periprosthetic leaks with prostheses in the aortic and mitral areas, one separation from suture material after vascular suture, one pledget migration, and one mild acute inflammatory reaction were experienced.

• Brand Name: PTFE POLYMER PLEDGETS
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8895614
• Report Number: 9612501-2019-01567
• Device Sequence Number: 18914472
• Product Code: GAT
• UDI-Device Identifier: 10884521550698
• UDI-Public: 10884521550698
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K930591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VPG36SE
• Device Catalogue Number: VPG36SE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other