MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA PLUS VASCULAR COVERED STENT SYSTEM

Catalog Number AASME07080

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Pain (1994); Obstruction/Occlusion (2422)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

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.The catalog number identified has not been cleared in the u.S.But, it is similar to the covera vascular covered stent products that are cleared in the us.The 510 k number and pro code for the covera vascular covered stent products are identified.

Event Description

It was reported that in a two stent procedure, the stent graft deployed and allegedly migrated, slightly covering 1-2mm of the iliac artery.It was further reported that four additional devices were used to resolve the issue and that the patient experienced pain.The patient was taken to the icu for one night and spent two nights in a hospital ward before being discharged.Reportedly, the patient is stable post-procedure.

Event Description

It was reported that in a two stent procedure in the iliac artery, the stent graft deployed and allegedly did not jump 1-2 mm as expected by the healthcare provider (hcp).It was further reported that four additional devices were used to resolve the issue and that the patient experienced pain.The patient was taken to the icu for one night and spent two nights in a hospital ward before being discharged.Reportedly, the patient is stable post-procedure.

Manufacturer Narrative

H10: manufacturing review: the lot number was provided, and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: cd with x-rays was provided for evaluation.A malposition of the stent leading to a partial coverage of the ostium of the internal iliac artery can be confirmed; however, no deficiency of the placed stent can be identified.A definite root cause for the event could not be determined.Labeling review: current version of ifu supplied with this product: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the deployment procedure of the covered stent.The ifu states: "under radiographic guidance, advance the delivery system over the guidewire past the target lesion and then pull back slightly on the entire system to attain correct positioning of the radiopaque markers.Use the radiopaque covered stent ends to center the covered stent across the lesion.(.) with your free hand, maintain a stationary hold on the white stability sheath during covered stent deployment and adjust for placement accuracy if necessary (.).Hold the white stability sheath as close as possible to the introducer without touching the dark brown moving catheter of the distal catheter assembly.Maintain the remainder of the white stability sheath (.) relaxed and avoid tension.(.).Do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement.(.) for accurate placement, subtle repositioning may be performed during initial wheel activation while the covered stent is still compressed in the catheter.".Potential complications and adverse events were found to be addressed; e.G.The ifu states: delivery system specific events that could be associated with clinical complications may include inaccurate deployment.The catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the covera vascular covered stent products that are cleared in the us.The 510 k number and pro code for the covera vascular covered stent products are identified in d2 and g5.H10: b5, g4.H11: d1, d4(product catalog no., lot no.), e1, e3, h6(device code, results, conclusion).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.

• Brand Name: COVERA PLUS VASCULAR COVERED STENT SYSTEM
• Type of Device: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9578409
• MDR Text Key: 177153430
• Report Number: 9681442-2019-00257
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P170042
• 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: 02/10/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASME07080
• Device Lot Number: ANDV2727
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 62