MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-02-22 for EMBOZENE? MICROSPHERES 01-0301-09002-01 19020-S1 manufactured by .
[68083293]
(b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68083294]
The patient presented with an important anemia following a lymphatic vessel density (lvd) which diagnosed a uterine-venous dysfunction. The patient presented with brutal desaturation with the emergence of a mediothoracic pain. An urgent embolization using 900um embozene? Microspheres was performed. Following embolization on the right side, thoracic pain appeared. Balances taken prior to the procedure did not reveal any particular pulmonary passage. Upon clinical examination, an important jugular turgidity presented. The exam performed revealed compatible images with hyperperfusion areas with pulmonary edema in incipient state. The procedure was stopped and the reanimation team was called in. The patient was transferred to the post-interventional surveillance room for further exams. The patient appeared to be in stable condition but remained intubated two days post-procedure.
Patient Sequence No: 1, Text Type: D, B5
[74390943]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[74390964]
It was further reported that the patient presented with a visual blur and a headache. A pelvic ultrasonography performed showed a pseudo-aneurysm of the anterior wall of the uterus and a right ovarian cyst of haemorrhagic appearance. The angioscanner performed on (b)(6) 2017 showed an arteriovenous malformation intrauterine without an arterial anomaly and a cyst of fluid to the right ovary. The interventional radiological treatment is performed. Absence of direct arteriovenous shunt with interposition of nidus between the arterial and venous side of this malformation is noted. A bilateral embolization using 900um embozene? Microspheres and another manufacturer's 700-900um is performed. During the procedure, the patient developed an acute respiratory distress associated to a chest pain, 76% desaturation in ambient air, and a sinus tachycardia to 130 bpm. The procedure is interrupted and the patient is intubated in rapid sequence without difficulty. During intubation, the noradrenaline is introduced before the appearance of a hemodynamic failure. An angiography scanner is performed to recover dilatation of the right cavities compatible with areas of hyperinfusion. There is no endominal failure in the pulmonary artery. Echocardiography reveals an acute pulmonary heart with a paradox septum and a paps estimated at 65mmhg. The patient was transferred to the reanimation unit, in this context of pulmonary heart, probably due to an inadequate distal pulmonary embolism of the microbeads. The patient was treated and satisfactory organ infusion was maintained. The haemorrhage was successfully stopped and the patient experienced a complete recovery with normalization of the pulmonary arterial blood pressure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2017-01209 |
| MDR Report Key | 6351105 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-22 |
| Date of Report | 2017-01-26 |
| Date of Event | 2017-01-24 |
| Date Mfgr Received | 2017-04-12 |
| Date Added to Maude | 2017-02-22 |
| 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 | EMP. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOZENE? MICROSPHERES |
| Generic Name | EMBOLIC DEVICE |
| Product Code | NAJ |
| Date Received | 2017-02-22 |
| Model Number | 01-0301-09002-01 |
| Catalog Number | 19020-S1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-22 |