MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT

Catalog Number ZVM10120

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Pain (1994); No Consequences Or Impact To Patient (2199); Obstruction/Occlusion (2422)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

Medical records were provided to the manufacturer for review.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.The catalog number identified has not been cleared in the u.S.But, it is similar to the e-luminexx vascular stent products that are cleared in the us.The 510 k number and pro code for the e-luminexx vascular stent products are identified.(expiry date: 08/2020), (b)(4).

Event Description

It was reported that after stent placement for a kissing stent (stent and stent graft) procedure in the left external iliac artery, the stent allegedly occluded and the patient experienced pain at the treatment site.The patient was diagnosed with ischemia in the left leg due to a plaque rupture and was transferred to another hospital for emergency thrombolysis treatment.The hospitalization was reportedly extended as the patient was diagnosed with compartment syndrome the next day.The current patient status is unknown.

Manufacturer Narrative

H10: this supplemental mdr is being sent to document a reportability change from a serious injury to not-reportable.Based on new information received from the healthcare provider reporting that there was no causal relationship between the covered stents, vascular stent and the patient adverse event and that there was no alleged device deficiency, the event no longer meets the definition of a complaint and will no longer be reportable to the fda.The catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the e-luminexx vascular stent products that are cleared in the us.The 510 k number and pro code for the e-luminexx vascular stent products are identified in d2 and g5.H10: b5, d4(expiry date: 08/2020).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that after successful placement of two covered stent grafts in the right and left common iliac artery and the vascular stent distally, an alleged occlusion was identified in the vascular stent (not related to the covered stent grafts and vascular stent) caused by ruptured plaque in the left common femoral artery.Post operatively, the patient experienced severe pain, acute limb ischemia, and prolonged hospitalization.There was no reported causal relationship between the vascular stent and the patient adverse event.

• Brand Name: E-LUMINEXX VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9693970
• MDR Text Key: 182329885
• Report Number: 9681442-2020-00045
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741147173
• UDI-Public: (01)00801741147173
• Combination Product (y/n): N
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVM10120
• Device Lot Number: ANBV2368
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 73