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

Model Number AVSM09080

Device Problem Positioning Failure (1158)

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

Event Date 05/17/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, stent allegedly did not open.There was no reported patient injury.

Manufacturer Narrative

H10: a voluntary recall has been initiated for the covera vascular covered stent which was product catalog/lot number specific.Reportedly the covera vascular covered stent has the potential to exhibit deployment issues (i.E., failure to deploy the covered stent) due to slide block bond failures in the device handle.Full or partial failure of the product to deploy is most likely to require percutaneous replacement with existing access.In rare cases, iatrogenic vascular injury may occur as the result of device withdrawal, manipulation, or abrupt/unexpected movements, particularly in the context of difficult or partial stent deployment or mispositioning.Adjunctive endovascular maneuvers may be indicated.There have been no cases where an open surgical procedure has been required.To date, there have been no reported patient injuries associated with deployment issues.As a result of the field action, this event is being reported as a malfunction reportable event.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 06/2023).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.

Manufacturer Narrative

H10: a voluntary recall has been initiated for the covera vascular covered stent which was product catalog/lot number specific.Reportedly the covera vascular covered stent has the potential to exhibit deployment issues (i.E., failure to deploy the covered stent) due to slide block bond failures in the device handle.Full or partial failure of the product to deploy is most likely to require percutaneous replacement with existing access.In rare cases, iatrogenic vascular injury may occur as the result of device withdrawal, manipulation, or abrupt/unexpected movements, particularly in the context of difficult or partial stent deployment or mispositioning.Adjunctive endovascular maneuvers may be indicated.There have been no cases where an open surgical procedure has been required.To date, there have been no reported patient injuries associated with deployment issues.As a result of the field action, this event is being reported as a malfunction reportable event.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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the delivery system was not returned for evaluation.Photos were not provided for review which leads to inconclusive evaluation results.Based on available information and as no sample was returned, the investigation is closed with inconclusive result.A definite root cause for the reported event could not be found.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 the precautions prior to deployment, the instruction for use state: '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.Retraction of the distal catheter and deployment of the covered stent is initiated by rotating the large wheel on the handle.' 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: 06/2023), g3.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 during a stent placement procedure, stent allegedly did not open.There was no reported patient injury.

• Brand Name: COVERA 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: 17133075
• MDR Text Key: 317253517
• Report Number: 9681442-2023-00231
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106354
• UDI-Public: (01)00801741106354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVSM09080
• Device Catalogue Number: AVSM09080
• Device Lot Number: ANFT0463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: RES 91359
• Patient Sequence Number: 1