MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS; GELSOFT PLUS STRAIGHT

Model Number GELSOFT PLUS STRAIGHT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Local Reaction (2035)

Event Date 10/09/2021

Event Type  Injury  

Event Description

Serious adverse events were reported related to gelsoft plus prostheses.In (b)(6) and (b)(6) 2021, 6 different patients were implanted with glesoft plus straight prostheses.All 6 patients experienced systemic septic symptoms with fever, high inflammatory local response within the first 24 hours postoperatively.In all 6 cases bacteria/infection was not detected in wound swabs nor in blood cultures.In one case, the prosthesis had to be explanted, leading to life-threatening complications and to irreversible consequential damage with presumably lifelong care.

Manufacturer Narrative

Device information: 1.Cat 631508p - lot 21710963 - (b)(4).2.Cat 631508p - lot 21738467 - (b)(4).3.Cat 631508p - lot 21658411 - (b)(4).4.Cat 631508p - lot 21627121 - (b)(4).5.Cat 631508p - lot 21697742 - (b)(4).6.Cat 631508p - lot 21718971 - (b)(4).(b)(4).

Event Description

Serious adverse events were reported related to gelsoft plus prostheses.In (b)(6) 2021, (b)(4) different patients were implanted with glesoft plus straight prostheses.All (b)(4) patients experienced systemic septic symptoms with fever, high inflammatory local response within the first 24 hours postoperatively.In all (b)(4) cases bacteria/infection was not detected in wound swabs nor in blood cultures.In one case, the prosthesis had to be explanted, leading to life-threatening complications and to irreversible consequential damage with presumably lifelong care.

Manufacturer Narrative

Section h6 manufacturers narrative.Investigation findings - 213 - no device problem was found.Vascutek ltd completed review of the associated manufacturing and sterilisation records for these devices; all records indicate that they were manufactured and processed as per specifications.Investigation conclusion - 4315 - cause not established - for the following reasons 1.The investigation conducted by vascutek ltd.Concluded that the device was manufactured to specification.2.The reporting site tested all the associated patients for signs of infection; however none were found.3.The site advised that they could not confirm if the associated patients were allergic to any of the materials used in the construction of the grafts (e.G.Polyester material or the gelatin coating).4.Review of the supplied ifu booklet with this device type indicates that fever and localised inflammation of surgical sites are a known and expected outcome/adverse event associated with the implantation of gelsoft plus grafts.Vascutek considers this event as closed as no further investigation is possible.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.

• Brand Name: GELSOFT PLUS
• Type of Device: GELSOFT PLUS STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; renfrewshire, PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 13007988
• MDR Text Key: 286747982
• Report Number: 9612515-2021-00030
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115337
• UDI-Public: 05037881115337
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GELSOFT PLUS STRAIGHT
• Device Catalogue Number: 631508P-G
• Device Lot Number: REFER TO SECTION H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention