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

Model Number	GELSOFT PLUS STRAIGHT
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: GELSFOT PLUS STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 10578693
• Report Number: 9612515-2020-00009
• Device Sequence Number: 3123880
• Product Code: DSY
• UDI-Device Identifier: 05037881115375
• UDI-Public: 05037881115375
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K162803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention