MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD CAROTID PATCH KNITTED ULTRATHIN; VASCULAR POLYESTER GRAFT

Model Number HGK10/75CPUT (1)

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

A review of the device history records, indicated that the patch was processed and inspected according to procedures and was therefore released following acceptable quality inspections and tests.Specifically, no anomaly was evidenced in the collagen coating records.The review of the water permeability testing records of products coated on the same day as the complaint device indicated values well within product specifications.Please note that water permeability testing is recognized by international standard for vascular patches as the test to address the risk of blood leakage.One retention sample coated on the same day and under the same conditions as the involved device underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).An unused remaining fragment of the involved device was available for investigation.It was sent to an external and independent laboratory for examination.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.

Event Description

It was reported that during a patch angioplasty performed on the common carotid artery, bleeding occurred after releasing the vascular clamps.The bleeding was observed in the middle of the patch on the black reference line.After suturing with a 7/0 prolene, the hole became bigger and multiple bleedings occurred, with necessitated to suture the patch with a pledget to stop the bleeding.The surgery was significantly prolonged.It was reported that the patient is well.

Manufacturer Narrative

A remaining fragment of the involved device was returned for examination and it was sent to an external and independent laboratory.The objective of the study was to evaluate the presence of any structural abnormality visible on the external and internal sides of the returned patch fragment and to evaluate the presence of collagen material.The analysis consisted of a macroscopic observation of the fragment and a scanning electron microscopy (sem).The sem analysis pointed out an abundant infiltration of collagen material with no obvious abnormality such as tears, loss of textile cohesion, holes and signs of cut.The sem analysis corroborated the macroscopic analysis.In addition, the review of the macroscopic pictures performed by our textile supervisor confirmed the absence of defects on the textile structure.No conclusion can be drawn.The conducted investigation and testing performed would tend to indicate that the product was not defective at the time of manufacturing.However, a non-conformity report has been initiated in order to take appropriate corrective actions if necessary.

Manufacturer Narrative

The case has been submitted to the corporate medical officer for review.His medical opinion is reported as follows : "i reviewed the complaint details.An hemagard patch knitted ultrathin was used in a routine carotid endarterectomy procedure.Bleeding was observed in the middle of the patch (the amount was not specified).After an attempt from the surgeon to reduce the bleeding with a 7/0 proline suture, the bleeding became more significant and a pledged suture was necessary to stop the bleeding.The patch remained in place and the procedure was concluded without any further clinical consequence.The origin of the bleeding remains unclear.A sem analysis was performed on the unused remaining fragment of the patch and no structural anomalies were detected." the additional information does not modify the conclusions provided in the initial report.

• Brand Name: HEMAGARD CAROTID PATCH KNITTED ULTRATHIN
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7141507
• MDR Text Key: 95586631
• Report Number: 1640201-2017-00039
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014928
• UDI-Public: 00384401014928
• Combination Product (y/n): N
• PMA/PMN Number: K983819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2018

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: No Information
• Device Expiration Date: 06/30/2022
• Device Model Number: HGK10/75CPUT (1)
• Device Catalogue Number: HGK10/75CPUT (1)
• Device Lot Number: 17G20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 02/20/2018; 05/30/2018
• Supplement Dates FDA Received: 03/20/2018; 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEPARIN; PLATELET - INHIBITING DRUGS; HEPARIN; PLATELET - INHIBITING DRUGS
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR