MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR; VASCULAR POLYESTER GRAFT

Device Problem Material Integrity Problem (2978)

Patient Problems Pseudoaneurysm (2605); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product identification has not been obtained at the date of this report, therefore no device history records evaluation could have been performed.It was reported that the device is not available for investigation.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.

Event Description

The hospital reported patient was born with an interrupted aortic arch.At some point an hemashield graft was implanted as in interposition graft connecting the aorta.The physician reported that this is the 3rd patient concerned by this problem and that the graft has disintegrated over time.The patient was treated with a cook zenith alpha thoracic stent graft (28x155) and an icast (9x59) was snorkeled into the subclavian artery.It was reported that the case was a success.This event is linked to the 2 other medical device reports 1640201-2017-00025 and 1640201-2017-00026.

Manufacturer Narrative

In spite of repeated efforts, no additional information could be obtained.Therefore, no conclusion can be drawn.

Event Description

In spite of repeated efforts including a follow-up visit performed on (b)(6) the (b)(6) in the hospital by the corporate medical officer, no additional information could be obtained.

Manufacturer Narrative

Despite repeated attempts, product identification was never provided by the hospital.Therefore, no manufacturing investigations, including the review of the device history records, could be conducted.(4112/213/180) the article was analyzed by the chief of pediatric cardiac surgery at (b)(6), who has been a user of hemashield vascular grafts since the beginning of his now 20+ years practice.He has never encountered anything even similar to the events described in the article.He also stated that because these events have been described in one center only versus few single isolated occurrences described in the literature, a root cause should be considered from the way the grafts were handled during the initial operation and on any subsequent endovascular intervention performed on these patients.(4109/213) besides these four cases in (b)(6), no associated or similar cases with hemashield grafts have been found in any other complaint cases to date.(4315) the cause of the events remains undetermined.Graft handling during the initial procedure and subsequent endovascular procedures performed on these patients should not be excluded as potential causes of the event.

Manufacturer Narrative

As the date of implantation of the graft was unknown until now, section f was completed by mistake in initial report.There is no importer to be mentioned and no exemption to be applied.Device is not accessible for testing as it is still implanted in the patient.A thorough analysis of the published article by a qualified healthcare professional will be provided.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

This 29-year-old male patient's cardiac anatomy consisted of an interrupted aortic arch (type b), as well as a ventricular septal defect and a stenotic, bicuspid aortic valve.Two 2 × 6-mm gore-tex interposition grafts were placed as the first stage of palliation during infancy, as well as a band on the main pulmonary artery.The ventricular septal defect was closed a month later, and the following year the patient underwent a surgical aortic valvuloplasty with patch enlargement of the ascending aorta.Six years after birth, the patient underwent replacement of the gore-tex interposition grafts with a 16-mm hemashield tube graft.After a 12-year period, the patient required stenting of the distal portion of the tube graft, which preceded a konno procedure with replacement of the aortic valve with a 27-mm mosiac porcine valve (medtronic).Seven years after the konno procedure, the patient developed mediastinitis, and required open debridement and wound vac placement.As part of his evaluation for the mediastinal infection, computed tomography (ct) imaging was obtained that demonstrated an 8-mm pseudoaneurysm at the distal aspect of the previously placed stent.His aortic arch was serially imaged over the following 3 years, which showed stable dilation of the aortic root, ascending aorta, and pseudoaneurysm.Prior to onset of symptoms at age 29, the patient was treated with a 28-mm × 155-cm zenith alpha endograft, 22 years following the initial placement of the hemashield tube graft.This complaint case was reopened following the publication of the article: aurigemma d, borquez a, lee j, et al.Non-anastomotic failure of woven dacron tube grafts in the thoracic aorta in young adults.J card surg.2018;33:653-657.This event is described as "case 4" in the article and took place somewhere between march 2014 and march 2017.The 3 other cases described in the article are reported in the following medical device reports: case 1 = (b)(4).Case 2 = (b)(4).Case 3 = (b)(4).

• Brand Name: HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 6724440
• MDR Text Key: 80410250
• Report Number: 1640201-2017-00024
• Device Sequence Number: 1
• Product Code: MAL
• Combination Product (y/n): N
• PMA/PMN Number: K021213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/11/2017
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR