MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT; GELSOFT ERS AX-FEM

Model Number GELSOFT ERS AX-FEM

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

Suspect medical device: only catalogue number has been supplied by site.No serial or batch/lot number provided.Only the year the device was implanted provided: 2012.Device manufacturer: as no serial/batch/lot number was provided device manufacture date is unknown.(b)(4).Testing of actual device: the graft or a sample of the graft has been returned however decontamination and investigation has not yet begun.Historical data analysis: a 5-year review of similar events for gelsoft grafts was carried out.- only 2 previous events have occurred in the past 5 years giving an occurrence rate of 0.002% (complaints v sales).Conclusion not yet available - vascutek ltd.Is awaiting further information on device batch or serial number and investigation into the returned device has yet to be completed.When further information is received and/or investigation is complete vascutek ltd, will report findings in next follow up / final report.

Event Description

Event was reported to vascutek ltd, on (b)(6) 2019 as follows: graft torn: year 2012: an axillo-femoral bypass with the gelsoft ers straight graft was performed.(b)(6) 2019: the graft around the costal cartilages was torn when the patient fell over.Luckily, there was very little hematoma.The torn graft was replaced with a competitor's graft.(type and manufacturer unknown).

Manufacturer Narrative

Additional manufacturers narrative: patient code - 3190 - no information - no information received on patient or specific batch information on device at this time.Device code - 2978 - material integrity problem.Device code - 4008 - material split, cut or torn - site reported that the graft tore around.The costal cartilages when the patient fell.Method code - 10 - testing of actual device - a sample of the actual graft was returned for investigation.Method code - 4109 - historical data analysis - a 5-year review of similar events for gelsoft grafts was carried out.(b)(4).Result code - 174 - material and / or chemical problem identified.Result code - 135 - degradation problem identified- investigation of the returned sample.Showed tear and holes in fabric.Conclusion code - 4315 -cause not established - root cause of the event could not be determined from investigation or information provided.Vascutek ltd.Was informed that no further information was available from site and therefore now considers this complaint closed.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.

Event Description

Event was reported to vascutek ltd, on (b)(6) 2019 follows: graft torn: year 2012: an axillo-femoral bypass with the gelsoft ers straight graft was performed.(b)(6) 2019: the graft around the costal cartilages was torn when the patient fell over.Luckily, there was very little hematoma.The torn graft was replaced with a competitor's graft.(type and manufacturer unknown).

• Brand Name: GELSOFT
• Type of Device: GELSOFT ERS AX-FEM
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 8872850
• MDR Text Key: 217436860
• Report Number: 9612515-2019-00021
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K002007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/12/2019,08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GELSOFT ERS AX-FEM
• Device Catalogue Number: 680010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2019
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2019
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention