MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-12-07 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR manufactured by Maquet Cardiovascular Llc.
[129622314]
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.
Patient Sequence No: 1, Text Type: N, H10
[129622315]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2018-00029 |
| MDR Report Key | 8142287 |
| Report Source | LITERATURE |
| Date Received | 2018-12-07 |
| Date of Report | 2018-12-07 |
| Date Mfgr Received | 2018-11-08 |
| Date Added to Maude | 2018-12-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. LAURE FRAYSSE |
| Manufacturer Street | Z.I. ATHELIA I |
| Manufacturer City | LA CIOTAT CEDEX, 13705 |
| Manufacturer Country | FR |
| Manufacturer Postal | 13705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR |
| Generic Name | VASCULAR POLYESTER GRAFT |
| Product Code | MAL |
| Date Received | 2018-12-07 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Address | 45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-07 |