MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNK FLUENCYPLUS VASC STNT GRFT; VASCULAR STENT GRAFT

Catalog Number UNK FLUENCYPLUS VASC STNT GRFT

Device Problem Obstruction of Flow (2423)

Patient Problems Ischemia (1942); Occlusion (1984)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified.As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal citation: d¿oria, m., pipitone, m., riccitelli, f., mastrorilli, d., calvagna, c., zamolo, f., & griselli, f.(2018).Successful off-label use of an iliac branch device to rescue an occluded aortofemoral bypass graft.Journal of endovascular therapy, 26(1), 128¿132.Doi: 10.1177/1526602818815699.

Event Description

It was reported in an article from journal of endovascular therapy titled, "successful off-label use of an iliac branch device to rescue an occluded aortofemoral bypass graft," that two years after the placement of the stent graft, the patient was admitted to the hospital for acute right limb ischemia and the absence of a right femoral pulse.A duplex ultrasound confirmed the occlusion of the external iliac artery (eia) stent graft therefore, recanalization of the eia and the right aortofemoral bypass was performed, however, it was later occluded and revised endovascularly.The postoperative course was uneventful and the patient was discharged 3 days after the rescue procedure.

• Brand Name: UNK FLUENCYPLUS VASC STNT GRFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9371121
• MDR Text Key: 168102836
• Report Number: 9681442-2019-00237
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK FLUENCYPLUS VASC STNT GRFT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR