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

Model Number GELSOFT PLUS STRAIGHT

Device Problems Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)

Patient Problem Aneurysm (1708)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer narrative: (b)(4).Type of investigation: trend analysis - review of similar complaints for all gelsoft plus / gelsoft devices and leakage gave an occurrence rate of (b)(4).Type of investigation: communication/interviews - information received from site indicated that the device was not pre-soaked prior to procedure contrary to ifu warnings and precautions which state "the prosthesis must be immersed in a sterile saline solution for 5 minutes.Failure to rinse for 5 minutes could lead to the graft being more susceptible to leakage when implanted" type of investigation: analysis of production records - review of qc and manufacturing records with attention to all in process and base material porosity tests showed batch was manufactured to design specification and all porosity testing on gelled product and base material met acceptance criteria.Type of investigation - 4114 - device not returned - device remains implanted and was not returned for further investigation.Investigation findings: no device problem found - no issue was found with manufacture of the batch on review of production records investigation conclusion: caused traced to user - information received from site indicated that the device was not pre-soaked prior to use as recommended in ifu to improve device handling.This may have been a contributory cause of the leakage seen.Investigation conclusions: failure to follow instructions - user did not follow instructions in ifu regarding pre-soak of device.Vascutek ltd.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 reported from maastricht umc+, netherlands as follows: "no relevant medical history.Patient came with symptomatic aaa.No antiplatelet.5000u heparin clamping aorta, proximal anastomosis.Clamping direct under proximal anastomosis, making distal anastomosis.After releasing the clamp, 3 small holes in mid segment of graft.1 hole is sutured, other 2 holes closed by manual compression.The event had no consequences for post-operative treatment.".

• Brand Name: GELSOFT PLUS
• Type of Device: GELSFOT 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: 10578693
• MDR Text Key: 208338328
• Report Number: 9612515-2020-00009
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115375
• UDI-Public: 05037881115375
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K162803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: GELSOFT PLUS STRAIGHT
• Device Catalogue Number: 631516P-G
• Device Lot Number: 17601137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention