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

Catalog Number AASLE10060

Device Problems Loss of or Failure to Bond (1068); Break (1069); Positioning Failure (1158); Detachment of Device or Device Component (2907)

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

Event Date 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number 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 common device name and pma/510k.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.However, photo was provided for review.The investigation of the reported event is currently underway.Expiry date: 10/2023.

Event Description

It was reported that during a stent graft placement procedure, the device allegedly failed to deploy.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.Based on the evaluation of the sample, the bond between slide block, release wire (tether) and proximal sheath was determined to not be maintain upon release forces.The stent was found completely deployed upon sample receipt, and detachment of the kink protector and the stability sheath, together with the break of the proximal sheath were confirmed; however, it is not known when and how this occurred.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 definite root cause is not yet available.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 "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 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." and "0.035 inch (0.89 mm) guidewire of appropriate length introducer sheath with appropriate inner diameter and length." h10: d4 (expiry date: 10/2023), g3.H11: h6(result).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 graft placement procedure, the device allegedly failed to deploy.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: 14797129
• MDR Text Key: 302257681
• Report Number: 9681442-2022-00193
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136276
• UDI-Public: (01)00801741136276
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASLE10060
• Device Lot Number: ANFX4118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• 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