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

Catalog Number AASLE08100

Device Problems Loss of or Failure to Bond (1068); Break (1069); Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the covera vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent products are identified.Manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the sample was not returned for evaluation.Based on the information available the investigation is inconclusive for reported issue.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the instruction for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to failure to deploy and high deployment forces.Regarding correct deployment the instruction for use states: "retraction of the distal catheter and deployment of the covered stent is initiated by rotating the large wheel (g) on the handle.The large deployment wheel is used for the initiation of deployment and a slower deployment rate whereas the small deployment wheel (h) may be used for faster deployment after initiation."; "(.) maintain a stationary hold on the white stability sheath during covered stent deployment (¿).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." regarding preparation the instruction for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated." regarding accessories the instruction for use states: "the covera plus vascular covered stent device is an over-the-wire delivery system.The delivery system is compatible with 0.035-inch (0.89 mm) guidewires and 8f or 9f introducer sheaths.The delivery system is available in working lengths of 80 cm and 120 cm."; the packaging pictograms indicate the use of an 9f introducer.Expiry date: 10/2023.

Event Description

It was reported that during a covered stent placement procedure via left superficial femoral artery, the stent was allegedly failed to deploy.It was further reported that the sheath seems broken disconnected from the launcher inside the handle.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent products are identified in d2 and g4.H10: manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the sample was returned for evaluation.The delivery system was returned for evaluation and the slide block which is a force transmitting component was no longer connected to the proximal sheath.It is considered the disconnection of the slide block led to the reported impossibility to deploy the covered stent which leads to confirmed results.Based on evaluation of the sample the inability of an adhesive joint (slide block/tether/diving sheath) to withstand tension force during deployment is confirmed.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the instructions for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to failure to deploy and high deployment forces.Regarding correct deployment the instructions for use states: "retraction of the distal catheter and deployment of the covered stent is initiated by rotating the large wheel (g) on the handle.The large deployment wheel is used for the initiation of deployment and a slower deployment rate whereas the small deployment wheel (h) may be used for faster deployment after initiation."; "(.) maintain a stationary hold on the white stability sheath during covered stent deployment (¿).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." regarding preparation the instructions for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated." regarding accessories the instructions for use states: "the covera¿ plus vascular covered stent device is an over-the-wire delivery system.The delivery system is compatible with 0.035 inch (0.89 mm) guidewires and 8f or 9f introducer sheaths.The delivery system is available in working lengths of 80 cm and 120 cm."; the packaging pictograms indicate the use of an 9f introducer.H10: d4 (expiry date: 10/2023).G3, h6 (device).H11: h6 (method, result, 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.H3 other text : see h10.

Event Description

It was reported that during a covered stent placement procedure via left superficial femoral artery, the stent was allegedly failed to deploy.It was further reported that the sheath seems broken disconnected from the launcher inside the handle.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: COVERA PLUS VASCULAR COVERED STENT
• Type of Device: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15231352
• MDR Text Key: 305365350
• Report Number: 9681442-2022-00239
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136191
• UDI-Public: (01)00801741136191
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASLE08100
• Device Lot Number: ANFX2254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 109 KG