MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT ERS; GELSOFT AX-BIFEM EQUI-FLO ERS REINFORCED,

Model Number GELSOFT

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

Patient Problems Hematoma (1884); Patient Problem/Medical Problem (2688)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

Patient information - no patient details provided.Suspect medical device - implant date given as 7 years previous, no exact date provided.(b)(4).

Event Description

Event was reported to vascutek ltd.As follows: blood leakage: the patient underwent abdominal aortic replacement for abdominal aortic aneurysm (aaa) seven years ago, and the gelsoft ers equi-flo bifurcated axillo-bifemoral graft was implanted then.After the procedure, the patient had regular checkups.Three years ago, computerized tomography (ct) imaging showed something like seroma.According to the latest checkup, it was revealed that the graft expanded.On (b)(6) 2020, the patient had a surgery.The physician confirmed that blood leaked from the bifurcation point of the graft.The physician removed the bifurcation point and replaced with a j graft.No serious damage to patient health was reported post-op.Further information received on 28-jan-20 stated the following."hematoma created by blood leakage and layers of hematoma were formed and enlarged".No images of hematoma or any scans from the period the graft had been implanted were provided.Further information received 05-feb-20: sketch of graft leakage shows that leakage did not occur at bifurcation but along length of main body of graft creating hematoma.

Manufacturer Narrative

Manufacturer narrative section a - patient information - no patient details provided.Section d - suspect medical device - implant date given as 7 years previous, no exact date provided.Patient code - 1884 - hematoma - customer reported large hematoma formed due to graft leakage.Device code - 2978 - material integrity problem.Device code - 2205 - material perforation.Device code - 1504 - material puncture/hole - customer believes that a hole or holes in graft has led to hematoma being formed.Method code - 10 - testing of explanted section of graft will be carried out.Method code - 4109 - historical data analysis - a 5-year similar event review for leakage of gelsoft devices was carried out (b)(4).Method code - 3331 - analysis of production records - review of qc and manufacturing records show that the batch was manufactured to specification - no issues were found with base material of in process leakage testing.Result code - 3233 - results pending completion of investigation - investigation into explanted section is ongoing.Conclusion code - 11 - conclusion not yet available - investigation into complaint is ongoing - results of investigation will be reported in next follow up / final report.Follow up report 1 20-feb-2020: investigation of explanted device is still ongoing - returned explanted device was received in 2 sections_ 1 section of body of device and 1 section of branch.Initial visual inspection with magnifier could not detect any holes in returned samples.Investigation into returned samples is still ongoing and results of investigation will be reported in next follow up final report.

Event Description

This report is being submitted as follow up #1 for mfg report #9612515-2020-00001 to provide additional information regarding vak ref: comp 3987 which was reported as follows: blood leakage: the patient underwent abdominal aortic replacement for abdominal aortic aneurysm (aaa) seven years ago, and the gelsoft ers equi-flo bifurcated axillo-bifemoral graft was implanted then.After the procedure, the patient had regular checkups.Three years ago, computerized tomography (ct) imaging showed something like seroma.According to the latest checkup, it was revealed that the graft expanded.On (b)(6) 2020, the patient had a surgery.The physician confirmed that blood leaked from the bifurcation point of the graft.The physician removed the bifurcation point and replaced with a j graft.No serious damage to patient health was reported post-op.Further information received on 28-jan-20 stated the following."hematoma created by blood leakage and layers of hematoma were formed and enlarged" no images of hematoma or any scans from the period the graft had been implanted were provided.Further information received 05-feb-20: sketch of graft leakage shows that leakage did not occur at bifurcation but along length of main body of graft creating hematoma.

Event Description

This report is being submitted as follow up #2/ final report for mfg report #9612515-2020-00001 to provide additional information and result of device evaluation regarding vak ref: (b)(4) which was reported as follows: blood leakage: the patient underwent abdominal aortic replacement for abdominal aortic aneurysm (aaa) seven years ago, and the gelsoft ers equi-flo bifurcated axillo-bifemoral graft was implanted then.After the procedure, the patient had regular checkups.Three years ago, computerized tomography (ct) imaging showed something like seroma.According to the latest checkup, it was revealed that the graft expanded.On (b)(6) 2020, the patient had a surgery.The physician confirmed that blood leaked from the bifurcation point of the graft.The physician removed the bifurcation point and replaced with a j graft.No serious damage to patient health was reported post-op.Further information received on 28-jan-20 stated the following."hematoma created by blood leakage and layers of hematoma were formed and enlarged." no images of hematoma or any scans from the period the graft had been implanted were provided.Further information received 05-feb-20: sketch of graft leakage shows that leakage did not occur at bifurcation but along length of main body of graft creating hematoma.

Manufacturer Narrative

Manufacturer narrative: section d - suspect medical device - implant date given as 7 years previous, no exact date provided.Section h6: patient code - 1884 - hematoma - customer reported large hematoma formed due to graft leakage.Device code - 2978 - material integrity problem.Device code - 2205 - material perforation.Device code - 1504 - material puncture/hole - customer believes that a hole or holes in graft has led to hematoma being formed.Method code - 10 - testing of explanted section of graft will be carried out.Method code - 4109 - historical data analysis - a 5-year similar event review for leakage of gelsoft devices was carried out and found 6 events in total inclusive of this one giving an occurrence rate of (b)(4).Method code - 3331 - analysis of production records - review of qc and manufacturing records show that the batch was manufactured to specification - no issues were found with base material of in process leakage testing.Result code - 213 - no device problem found - review of device qc and manufacturing records showed device was manufactured to design specification and no issue was found on analysis of the returned graft (see attached evaluation report) conclusion code - 4315 - cause not established - no definitive root cause could be established from the testing of the device and review of device history records.

• Brand Name: GELSOFT ERS
• Type of Device: GELSOFT AX-BIFEM EQUI-FLO ERS REINFORCED,
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 9675199
• MDR Text Key: 191040035
• Report Number: 9612515-2020-00001
• 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,Followup
• Report Date: 01/10/2020,08/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: GELSOFT
• Device Catalogue Number: 691008B
• Device Lot Number: 108814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2020
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2020
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 01/10/2020; 01/10/2020
• Supplement Dates FDA Received: 03/06/2020; 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention