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

Catalog Number AASLE09040

Device Problems Misfire (2532); Malposition of Device (2616); Activation Failure (3270)

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

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

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.However, photos were 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 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.Expiration date: 06/2023.Device pending return.

Event Description

It was reported that during a stent placement procedure in the right common iliac artery via a right femoral puncture, the stent partially opened up and got stuck.The device was removed off the patient and was tried to get it deployed; however, the full stent allegedly jumped out of the system.The procedure was completed using another device.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 stent delivery system was returned for evaluation, with the covered stent separately enclosed completely deployed.A segment of the delivery system - the metal guiding tube including the luer lock adapter - protruded out of the proximal end of the handle.Based on the condition of the sample it could not be determined if the grip shells were disassembled by purpose or due to damage of the device.Besides the detachment of the luer adapter from the handle, no defects or any additional detachments of the inner assembly could be found, that may be related to the reported deployment issue.No indication for a manufacturing related cause could be found.In summary, neither the reported incomplete deployment nor the alleged sudden deployment outside the patient can be reproduced.A photo of the device was also provided, but is only showing the distal end of the system with the released covered stent; the photo was taken in an office area.Based on the information available and the evaluation of the sample, the reported incomplete deployment could not be reproduced.The investigation is closed with inconclusive result.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 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 theinstruction 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 instruction 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 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: d4 (expiration date: 06/2023), 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 : see h10.

Event Description

It was reported that during a stent placement procedure in the right common iliac artery via a right femoral puncture, the stent partially opened up upon deployment and got stuck.The device was removed off the patient and was tried to get it deployed when the full stent allegedly jumped out of the system.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure in the right common iliac artery via a right femoral puncture, the stent partially opened up upon deployment and got stuck.The device was removed off the patient and was tried to get it deployed when the full stent allegedly jumped out of the system.The procedure was completed using another device.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 stent delivery system was returned for evaluation, with the covered stent separately enclosed completely deployed.A segment of the delivery system - the metal guiding tube including the luer lock adapter - protruded out of the proximal end of the handle.Based on the condition of the sample it could not be determined if the grip shells were disassembled by purpose or due to damage of the device.Besides the detachment of the luer adapter from the handle, no defects or any additional detachments of the inner assembly could be found, that may be related to the reported deployment issue.No indication for a manufacturing related cause could be found.In summary, neither the reported incomplete deployment nor the alleged sudden deployment outside the patient can be reproduced.A photo of the device was also provided, but is only showing the distal end of the system with the released covered stent; the photo was taken in an office area.Based on the information available and the evaluation of the sample, the reported incomplete deployment could not be reproduced.The investigation is inconclusive for reported issues.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 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 theinstruction 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 instruction 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 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: d4 (expiration date: 06/2023), g3.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14020331
• MDR Text Key: 288655340
• Report Number: 9681442-2022-00103
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136214
• UDI-Public: (01)00801741136214
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2022

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: AASLE09040
• Device Lot Number: ANFT2624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 07/26/2022; 08/04/2022
• Supplement Dates FDA Received: 07/30/2022; 08/11/2022
• 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