MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Device Problem Defective Device (2588)

Patient Problems Embolism (1829); Hematoma (1884); Occlusion (1984); Perforation (2001); Thrombosis (2100); Stenosis (2263); Pseudoaneurysm (2605)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event: date of event - estimate.Implant date: date of implant - estimate.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature: a real-world experience with the supera interwoven nitinol stent in femoropopliteal arteries: midterm, patency results and failure analysis.

Event Description

This case was captured based on a literature review.It was reported through a research article that supera self expanding stents may be related to amputation, hematomas, pseudoaneurysms, deep vein thrombosis, occlusions, stenosis, calciphylaxis, perforation, distal embolization requiring aspiration thrombectomy/additional stenting and compartment syndrome requiring surgical fasciotomy.Additionally it was reported that occlusion of supera stents may be related to unrecognized and uncorrected intussusception of the stents [material deformation].Specific information is documented as unknown.Details are listed in the article, titled: "a real-world experience with the supera interwoven nitinol stent in femoropopliteal arteries: midterm, patency results and failure analysis.".

Manufacturer Narrative

Internal file number - (b)(4).Correction: outcomes attributed to adverse event - hospitalization added.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.The reported patient effects of embolism, hematoma, occlusion, perforation, thrombosis, restenosis and pseudoaneurysm are listed in the supera instructions for use as known patient effects associated with the use of the device.Based on the case information, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Additionally, a cause for the stent shortening could not be determined.It may be possible that anatomical conditions or not pulling the delivery system back to allow for proper stent deployment contributed to the reported shortening; however, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8695925
• MDR Text Key: 147897525
• Report Number: 2024168-2019-04664
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 75 YR