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

Model Number AVSM10060

Device Problems Obstruction of Flow (2423); Structural Problem (2506)

Patient Problem Occlusion (1984)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The sample was not returned to the manufacturer for inspection/evaluation, however medical images were provided for evaluation.The results of the anticipated image evaluation will be provided upon completion of the event investigation.

Event Description

It was reported that 12 days post successful covered stent placement procedure in the cephalic arch via right arm fistula approach, the patient reported waking with a throbbing pain in his shoulder.It was further reported that on (b)(6) 2019, under fluoroscopy, the covered stent had allegedly collapsed.The patient's access had clotted and a permacath was placed.

Event Description

It was reported that 12 days post successful covered stent placement procedure in the cephalic arch via right arm fistula approach, the patient reported waking with a throbbing pain in his shoulder.It was further reported that on (b)(6) 2019, under fluoroscopy, the covered stent had allegedly collapsed.The patient's access had clotted and a permacath was placed.

Manufacturer Narrative

H10: manufacturing review: the device history record of this lot was reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.Investigation summary: x-ray images from the day of initial stent placement as well as images from the day of fluoroscopy were provided.Based on the images of the index procedure the stent did properly expand.Based on images from the day of fluoroscopy, no statement can be made as to whether the structure of the stent is damaged.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the issue experienced by the customer could not be determined.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11: h6(results, 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.

• Brand Name: COVERA VASCULAR COVERED STENT
• Type of Device: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8622058
• MDR Text Key: 145495960
• Report Number: 9681442-2019-00067
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106392
• UDI-Public: (01)00801741106392
• Combination Product (y/n): N
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: AVSM10060
• Device Catalogue Number: AVSM10060
• Device Lot Number: ANCW2358
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 113