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

Catalog Number AASLE07080

Device Problems Loss of or Failure to Bond (1068); Break (1069); Difficult or Delayed Positioning (1157)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the covera plus vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent products are identified.(expiry date: 11/2022).Device pending return.

Event Description

It was reported that during a stent graft placement procedure, the string in stent thumbwheel was allegedly torn which causes unsuccessful stent deployment.It was further reported that the physician removed the deployment hub and tried with manual technique which got successful in deploying the stent.There was no reported patient injury.

Event Description

It was reported that during a stent graft placement procedure, the string in stent thumbwheel was allegedly torn which causes unsuccessful stent deployment.It was further reported that the physician removed the deployment hub and tried with manual technique which got successful in deploying the stent.There was no reported patient injury.

Manufacturer Narrative

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 found disassembled and the stent was found deployed and missing.The end of the tether was found broken out of the socket of the sliding block; however, the tether itself was not broken.The slide block was found no longer connected to proximal sheath.Based on the condition of the sample it is concluded that the slide block getting disconnected from the proximal sheath, led to the reported impossibility to deploy the stent using the deployment wheel.Subsequently, the tether broke off from the slide block when the physician continued to rotate the deployment wheel.In addition, the condition of the sample confirms the successful attempt of the physician to deploy the stent by manipulation of the inner assembly.In addition, photos were provided showing the condition of the device in the operation room; since the delivery system was physically returned, the images do not add significant value to the investigation.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 "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." h10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera plus vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent products are identified in d2 and g4.H10: (expiry date: 11/2022).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
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12337443
• MDR Text Key: 267106753
• Report Number: 9681442-2021-00443
• Device Sequence Number: 1
• Product Code: PFV
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASLE07080
• Device Lot Number: ANEY4307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• 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