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

Catalog Number AVSLE08080

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 02/06/2024

Event Type  malfunction  

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: 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.H10: d4 (expiry date: 11/2025) 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 pending return.

Event Description

It was reported that during a stent graft placement procedure, the catheter allegedly got stuck with the guidewire.It was further reported that the inner catheter was allegedly detached.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.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: delivery systems were not returned for evaluation.Based on photos provided breakage of the inner catheter of the delivery system is confirmed.Based on the photos there is no indication that any components may be left in the patient.Based on information available and photos provided breakage of the inner catheter of the delivery system is confirmed.Even though breakage of the inner catheter may be related difficulties to remove the system over the guidewire, the reported difficulties to remove the device after stent deployment could not be confirmed.A definite root cause for the reported issue could not be determined.Labeling review: relevant labeling supplied with this product was reviewed.Regarding material required for use of the device the instruction for use states: "0.035 inch (0.89 mm) guidewire of appropriate length to allow safe delivery of the covered stent and removal of the delivery system." h10: d4 (expiry date: 11/2025), g3, h6 (device).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 graft placement procedure, the catheter allegedly got stuck with the guidewire.It was further reported that the inner catheter was allegedly detached.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.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: an 8f delivery system of an 8x80 stent was returned for evaluation, including a separated inner catheter and a 0.035 inch hydrophilic guide wire.The safety lock slider was found to be in its unlocked position upon sample receipt; the stent was missing, as it had been placed in the patient.Based on the condition of the inner catheter it is considered that the inner catheter broke off.Also, photos of the device were provided, previously.Based on these photos provided breakage of the inner catheter of the delivery system is confirmed.Therefore, based on evaluation of the sample and information available breakage of the inner catheter of the delivery system is confirmed.Even though breakage of the inner catheter may be related difficulties to remove the system over the guidewire, the reported difficulties to remove the device after stent deployment could not be confirmed.Based on information available, a definite root cause for the reported issue could not be determined.Labeling review: relevant labeling supplied with this product was reviewed.Regarding material required for use of the device the instruction for use states: "0.035 inch (0.89 mm) guidewire of appropriate length to allow safe delivery of the covered stent and removal of the delivery system." h10: d4 (expiry date: 11/2025), g3, h2, h6 (method) 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 graft placement procedure, the catheter allegedly got stuck with the guidewire.It was further reported that the inner catheter was allegedly detached.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: 18825385
• MDR Text Key: 336754083
• Report Number: 9681442-2024-00030
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741105838
• UDI-Public: (01)00801741105838
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AVSLE08080
• Device Lot Number: ANHV1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• 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
• Patient Sequence Number: 1