MAUDE Adverse Event Report: VASCUTEK GELSOFT; GELSOFT EQUI-FLO

Model Number 690807B

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 10/22/2016

Event Type  Injury  

Manufacturer Narrative

The serial number & lot number are unknown therefore expiry date also unknown.The serial number & lot number are unknown therefore the approx.Age of the device is also unknown.(b)(4).Method code - will be provided in the final report.Results code - will be provided in the final report.Conclusion code - 11 - conclusion not yet available - evaluation in progress.Note - as the serial number & lot number are unknown we are unable to complete a review of manufacturing records for the device/lot.A 5 year review of similar reported events was completed for gelsoft grafts which gave a low occurrence rate of 0.003%.

Event Description

The patient had a gelsoft equi-flo graft implanted in 2007 during a bypass of the right axillary artery.The patient had a thrombectomy in 2011 due to the graft "clogging" at the branch.The patient had the distal part of the branch replaced with a gelsoft graft in 2012 due to "clogging" in (b)(6) 2016 the graft was "clogged" again at the branch area which was horizontally cut open to remove clots and the area was replaced by a gelsoft graft ct images in (b)(6) 2016 confirmed that there was another occlusion in the "upper part of the straight tube"; the patient underwent an emergency operation to remove the clot and have the clotted part replaced by a gelsoft straight graft.The patient is currently making progress after the last operation and has no infection.

Manufacturer Narrative

(b)(4).No batch# or serial# was provided therefore a review of manufacturing records could not be completed.A 5 year review of similar reported events was completed which gave a low occurrence rate of (b)(4) for all vascutek polyester products and (b)(4) for gelsoft grafts.Vascutek now considers this case closed, however, the issue will be tracked & trended as part of the on-going complaints monitoring and reporting process, if an adverse trend develops action may be taken at that time (b)(4).

Event Description

This report is being submitted as a follow-up # 1 for mfg.Report # 9612515-2016-00030 to provide additional information regarding vascutek's investigation.

• Brand Name: GELSOFT
• Type of Device: GELSOFT EQUI-FLO
• Manufacturer (Section D): VASCUTEK; newmains ave; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK; newmains ave; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains ave; inchinnan business park; renfrewshire, scotland PA4 9-RR ; UK PA4 9RR ; 418125555
• MDR Report Key: 6131501
• MDR Text Key: 61002528
• Report Number: 9612515-2016-00030
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P890045/S1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2016,12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 690807B
• Device Catalogue Number: 690807B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2016
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR