MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS

Catalog Number 636006P

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: actual device not evaluated - device was not returned to vascutek for analysis.Manufacturing review - manufacturing and qc records were reviewed.Results: no failure detected - manufacturing and qc records review showed that the device was manufactured to specification.Conclusion: off label, unapproved or contraindicated use - gelsoft plus is not indicated for thoracic use.A review of manufacturing and qc records confirmed that the device was manufactured to specification.Similar events review that covered polyester grafts for the past 5 years showed a very low occurrence rate of (b)(4) (complaints v sales).This is the first time vascutek received complaints for the graft elongation.There have been no similar complaints received from other units of the same batch.No negative trend in the number of complaints received was identified.Gelsoft plustm grafts are not indicated for carotid bypass use.As per ifu: gelsoft plustm are not recommended for thoracic use.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.Vascutek consider this case closed.

Event Description

Vascutek ltd.Was notified of an event that occurred in (b)(6) in (b)(6) 2017, the event was described as follows: gelsoft plustm straight graft was used for carotid bypass.Implant occurred in (b)(6) 2016.The graft became elongated over time (1-year period) to the point it was beginning to erode through the skin.As a result, the graft was replaced ((b)(6) 2018).

• Brand Name: GELSOFT PLUS
• Type of Device: GELSOFT PLUS
• 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: carolyn forrest ; newmains avenue; inchinnan business park; renfrewshire, PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 7525090
• MDR Text Key: 108607582
• Report Number: 9612515-2018-00006
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115023
• UDI-Public: 05037881115023
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2018,05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 636006P
• Device Lot Number: 386345-8987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2018
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention