MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMAGARD KNITTED; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number HGK1608

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

Patient Problem Stenosis (2263)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is manufactured by intervascular (b)(4).(b)(4) is the importer of the device.A follow up importer medical device report will be submitted once the results from the manufacturer are available.

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, 1640201-2019-00040, 1640201-2019-00041, 1640201-2019-00042, 1640201-2019-00043, 1640201-2019-00044.

Event Description

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

Event Description

See mfr report # 1640201-2019-00043.Complaint: #(b)(4).The remaining 6 other cases are reported in the following medical device reports: 1640201-2019-00039, 1640201-2019-00040, 1640201-2019-00041, 1640201-2019-00042 , 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 over end of 2016 to 2017.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.

• Brand Name: HEMAGARD KNITTED
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8952570
• MDR Text Key: 156304011
• Report Number: 2242352-2019-01000
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014027
• UDI-Public: 00384401014027
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2020

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: 08/31/2021
• Device Model Number: HGK1608
• Device Catalogue Number: HGK1608
• Device Lot Number: 16J08
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2020
• Distributor Facility Aware Date: 04/16/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 02/18/2020; 04/16/2020
• Supplement Dates FDA Received: 03/16/2020; 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention