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

Catalog Number AASLE08080

Device Problems Loss of or Failure to Bond (1068); Misfire (2532)

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

Event Date 03/25/2022

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the stent was allegedly partially deployed.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the covera vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2023).

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 that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent 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 delivery system was not returned for evaluation.However, a provided photo shows the stent partially deployed which leads to confirmed results for incomplete stent deployment.However, 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.The instruction for use state: "if unusual resistance is met during covered stent system introduction, the system should be removed and another covered stent system should be used".With regards to preparation and accessories, 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", "flush the delivery system through the luer port at the proximal end of the handle with sterile saline until the saline exits the tip of the system" and "0.035 inch guidewire of appropriate length (.), introducer sheath with appropriate inner diameter" should be used; the packaging pictogram indicates the use of an 8f introducer.Holding and handling of the system throughout deployment was found sufficiently described.H10: d4 (expiry date: 03/2023), g3 h11: g1, 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 : device not returned.

Event Description

It was reported that during a stent placement procedure, the stent was allegedly partially deployed.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 that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent 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 delivery system was returned for evaluation.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 stent which leads to confirmed results.Also, a provided photo shows the stent partially deployed.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.The instruction for use state: "if unusual resistance is met during covered stent system introduction, the system should be removed and another covered stent system should be used".With regards to preparation and accessories, the instruction for use state states "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated".Holding and handling of the system throughout deployment was found sufficiently described.H10: d4 (expiry date: 03/2023), g3, h6(device).H11: h6 (method, result and 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 stent placement procedure, the stent was allegedly partially deployed.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: 14166971
• MDR Text Key: 289751267
• Report Number: 9681442-2022-00120
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136184
• UDI-Public: (01)00801741136184
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASLE08080
• Device Lot Number: ANFQ3155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 06/09/2022; 06/30/2022
• Supplement Dates FDA Received: 06/13/2022; 07/06/2022
• 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