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

Device Problem Material Integrity Problem (2978)

Patient Problems Chest Pain (1776); High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Manufacturer Narrative

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 (b)(6) male patient's anatomy at birth consisted of dextrocardia (situs inversus totalis) with double outlet right ventricle and an interrupted aortic arch (type b).The first stage of palliation included a 6-mm gore-tex interposition graft, as well as banding of the main pulmonary artery.Several months later, he underwent repair of the ventricular septal defect.The following year, the interposition graft was upsized to a 12-mm hemashield tube graft.The patient did quite well over a 17-year period, requiring catheter-based intervention to stent the proximal (9 years after implant) and distal ends of the graft (11 years after implant), as well as further procedures to dilate previously placed stents (up to 14 mm).Seventeen years after the initial implant, in the setting of upper extremity hypertension, worsening exercise intolerance, and intermittent chest pain, the patient was taken to the operating room for up-sizing of the hemashield graft.The procedure was ultimately aborted secondary to significant bleeding.The graft was densely adherent to the chest wall and began to disintegrate during the dissection.The patient recovered from the unsuccessful attempt at replacing the graft.He was taken to the cath lab several months later, where an 18mm× 105 cm zenith alpha endograft (cook medical, bloomington, in) was placed across the tube graft.The endograft was reinforced with three max ld 36-mm stents (medtronic, minneapolis, mn), which were dilated to 18 mm.He has been asymptomatic in the 12 months since the procedure.Follow-up imaging has not identified any residual defects with the stented dacron graft.This complaint case was opened 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.Four cases are described in the article, including this case of which the manufacturer was not aware before the article publication.This event is described as "case 3" 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 = 1640201-2017-00025, case 2 = 1640201-2017-00026, case 4 = 1640201-2017-00024.

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 university of iowa, 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 san diego, 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.

• 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: 8142287
• MDR Text Key: 129622314
• Report Number: 1640201-2018-00029
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 18 YR