MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAPATCH KNITTED; VASCULAR POLYESTER GRAFT

Model Number	HEK25/100P (1)
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
((b)(4)) a review of the complaint device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly was found.Specifically, the review of the water permeability testing records of products coated on the same day and under the same conditions as the complaint device indicated values well within product specifications.((b)(4)) one retention sample coated on the same period and under the same conditions as the complaint device underwent water permeability testing at 120 mm hg as per iso 7198.The test result indicated a value well within product specifications.((b)(4)) no conclusion can be drawn.However, all available information and the product testing performed would tend to indicate that the device was not defective.
Event or Problem Description
Durin a cardiac operation performed on a small child, it was reported a leak from the patch which necessitated a revision surgery.The patient was reported as being fine.No additional information could be obtained at the date of this report.
Event or Problem Description
The involved patch was used to augment the aortic root and ascending aorta in the context of an operation to repair supra-valvular aortic stenosis and to repair the aortic valve.After reperfusing the aortic root, there was severe bleeding through the interstices of the patch, in addition to some expected needle hole bleeding from the suture line.After the visual inspection of the entire suture line, no surgical defect and no surgical bleeding were confirmed.Protamine was administrated to stop the patch leakage as well as the suture line needle hole bleeding.However, severe blood leak through the patch interstices persisted, despite adequate reversal of heparin and administration of clotting factors (fresh frozen plasma, platelets, fibrinogen, and various coagulation factors).Most of the bleeding continued through the fabric patch itself rather than the suture line, likely because of the larger surface area of the patch.The bleeding was so severe and persistent that continuous transfusion was necessary to major hemodynamic instability.Only option left to save the patient life was to resume hypothermic cardiopulmonary bypass, cross clamp the aorta and arrest the heart with cardioplegia, completely remove the patch, and replace it with another patch.Following reperfusion, rewarming, and termination of cardiopulmonary bypass, it was immediately evident that the new patch implanted was much better, had minimal seepage through its interstices and minimal suture line bleeding.Following reversal of anticoagulation and appropriate blood product, coagulation factor therapy to counteract of the previously described massive transfusion, bleeding finally stopped.The patient required prolonged icu stay because of the effects of the massive transfusion, but eventually recovered completely and was discharged home.
Additional Manufacturer Narrative
A traceability research was conducted in order to identify the other patches issued from the same intermediate product as the involved device.Indeed, patches are cut at the final step of the manufacturing process from a unique intermediate product (same coated textile band).Twelve other patches issued from this band, i.E.That underwent the same manufacturing conditions as the involved device, were identified.One patch was found available in our warehouse.(b)(4).The retrieved patch underwent water permeability testing, which is recognized by international standard for vascular grafts as the test to address the risk of blood leakage.The testing was supervised by our product control and calibration supervisor.The test result indicated a value (0 ml/cm²/min) well within product specifications (< 5 ml/cm²/min).Please also note that the eleven other patches issued from the same intermediate product have all been sold and no bleeding situation has been reported.(b)(4).No conclusion could be drawn.However, all investigation and testing performed would tend to indicate that the device was not defective.

• Brand Name: HEMAPATCH KNITTED
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6127161
• Report Number: 1640201-2016-00036
• Device Sequence Number: 10997411
• Product Code: DSY
• UDI-Device Identifier: 00384401001591
• UDI-Public: 00384401001591
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2016

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: No Information
• Device Expiration Date: 03/31/2021
• Device Model Number: HEK25/100P (1)
• Device Catalogue Number: HEK25/100P (1)
• Device Lot Number: 16D14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/25/2016
• Supplement Report FDA Received Date: 01/26/2017; 03/09/2017
• 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