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 2020-03-23 for FLUENCY PLUS VASCULAR STENT GRAFT FVL10100 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[187057455]
This emdr is being submitted to document the fact that this file has been changed from a malfunction to a serious injury. The event was previously determined to be reportable as a malfunction on 11/15/2019 and was reported to the fda through the quarterly voluntary malfunction summary reporting program. Mdr 9681442-2020-00023 was submitted and accepted by the fda on 01/14/2020. New information was received for this event on 02/26/2020 and the event was reassessed and determined to be reportable as a serious injury. Manufacturing review: the device history records have been reviewed and this lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: based on the investigation of the returned delivery system it was confirmed that the user could not regularly deploy the stent graft. The outer sheath was found fractured at the proximal end which was considered an indication that a complete deployment was impossible although the stent graft was not part of the sample return. Based on the event description the stent graft got entrapped inside the vessel which is only possible if the stent graft is not fully loaded. Elongation at the fracture site indicated that a high release force was present when the fracture occurred. An indication for a manufacturing related issue could not be found. Based on the information available and the evaluation of the sample, a fractured outer sheath of the delivery system was confirmed. However, a definite root cause for the reported issues during stent graft deployment could not be determined. Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential factors. Regarding preparation and accessories, the ifu state: 'a super stiff guide wire (0. 035 in. ) is advanced from a femoral artery puncture site. Use an introducer sheath for the implant procedure. Note: predilatation of the stenosis may be performed prior to stent graft deployment at the discretion of the physician. ', and 'prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline. Flushing these lumens will also facilitate stent graft deployment. ' ; the labels indicate an introducer size of 9f. Furthermore, the ifu state: 'prior to stent graft deployment, ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy. ' the catalog number identified has not been cleared in the u. S. But, it is similar to the fluency plus endovascular stent graft products that are cleared in the us. The 510 k number and pro code for the fluency plus endovascular stent graft products are identified.
Patient Sequence No: 1, Text Type: N, H10
[187057456]
It was reported that during treatment, the stent graft allegedly experienced deployment issues; reportedly, the proximal end of the stent graft punctured through the vessel lumen and went into the subcutaneous groin tissue. Therefore, the sheath dilator was used to block flow through the stent graft and prevent further blood extravasation until an open procedure. The current patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2020-00068 |
| MDR Report Key | 9868459 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2019-11-06 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-09-02 |
| Date Added to Maude | 2020-03-23 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Street | WACHHAUSSTRASSE 6 |
| Manufacturer City | KARLSRUHE 76227 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLUENCY PLUS VASCULAR STENT GRAFT |
| Generic Name | VASCULAR STENT GRAFT |
| Product Code | PFV |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2019-11-15 |
| Catalog Number | FVL10100 |
| Lot Number | ANDV0205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Address | WACHHAUSSTRASSE 6 KARLSRUHE 76227 GM 76227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-23 |