MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number HGK1407

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Device is not accessible for testing as it remained implanted in the patient.A review of the complaint device history records, indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.Specifically, no anomaly was evidenced in the collagen coating or textile records.The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.Not returned to manufacturer.

Event Description

Hemagard knitted bifurcated grafts were implanted over end of 2016 to 2017 on 21 patients.Among these patients, 7 have been recently followed up for stenosis of the graft.The date of onset of the adverse event is unknown.The stenosis area is inguinal, with almost same pattern for the 7 patients.The remaining 6 other cases are reported in the following medical device reports: 1640201-2019-00039, 1640201-2019-00041, 1640201-2019-00042, 1640201-2019-00043, 1640201-2019-00044, 1640201-2019-00045.

Event Description

See mfr report # 1640201-2019-00040.Complaint #(b)(4).The remaining 6 other cases are reported in the following medical device reports: 1640201-2019-00039, 1640201-2019-00041, 1640201-2019-00042, 1640201-2019-00043, 1640201-2019-00044, 1640201-2019-00045.

Manufacturer Narrative

(4109/213) an additional review performed on our historical data shows no complaints for similar events in the last 2 years, except these 7 events related to 6 different lots.Therefore, it remains an isolated series of events.The clinical assessment made by our medical corporate officer is as follows : "i reviewed the information regarding seven events of stenosis in bifurcated hemagard knitted grafts that have been implanted between 2017 and 2019.In one case the stenosis led to the occlusion of the graft.In 3 cases the stenosis was not critical and did not require an intervention.In 3 cases a balloon angioplasty was completed.The events were recorded as the surgeon found unusual the occurrence of a stenosis at the same location with similar characteristics.No additional information was provided regarding pre-existing patient's conditions and surgical technique.[¿] no further comment could be made because of the lack of additional information.¿ (4315) the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.No conclusion can be drawn.However, the conducted investigation suggests that the device was not defective at the time of manufacturing.We will continue to monitor complaint trends monthly to detect any further signals.

Event Description

See mfr report # 1640201-2019-00040.Complaint #(b)(4).The remaining 6 other cases are reported in the following medical device reports: 1640201-2019-00039, 1640201-2019-00041, 1640201-2019-00042, 1640201-2019-00043, 1640201-2019-00044, 1640201-2019-00045.

Manufacturer Narrative

We obtained more detailed information on the 7 patients outcome and current health condition.Among the seven patients, there were no deaths and no amputations.Also, of the seven patients, 3 had no additional procedure and 3 had angioplasty balloon.One patient who underwent angioplasty treatment recieved a stent.The last one had occlusion, therefore thrombectomy and pta were performed.Because the additionnal information provided by the hospital was not individualized, block b2 was not updated, the worst case amongst the 7 cases was considered.(4111/3221) as part of the investigation, communication/interviews with persons close to the adverse event (healthcare professional) took place in order to try to find the cause of the event.It was confirmed that the surgeon started to use hemagard in 2016.However, no more information could be furher obtained.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Manufacturer Narrative

Corrected data : block h10 : in the clinical assessment, there was a typo error confirmed today.Please read the first sentence of the clinical assessment as follows : ¿i reviewed the information regarding seven events of stenosis in bifurcated hemagard knitted grafts that have been implanted over end of 2016 to 2017.¿.

Event Description

See mfr report # 1640201-2019-00040.Complaint #(b)(4).The remaining 6 other cases are reported in the following medical device reports: 1640201-2019-00039, 1640201-2019-00041, 1640201-2019-00042, 1640201-2019-00043, 1640201-2019-00044, 1640201-2019-00045.

• Brand Name: HEMAGARD KNITTED
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 8950252
• MDR Text Key: 156144656
• Report Number: 1640201-2019-00040
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014386
• UDI-Public: 00384401014386
• Combination Product (y/n): N
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: HGK1407
• Device Catalogue Number: HGK1407
• Device Lot Number: 16E05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention