MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number UNK SUPERA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Dates estimated.The patient deaths and device malfunctions referenced will be filed under separate medwatch report #s.The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The udi is unknown as the part and lot numbers were not provided.Article title: clinical implications of the invagination of an interwoven nitinol stent: a single-center retrospective analysis.Na.

Event Description

It was reported through a research article identifying supera that may be related to the following: patient death, stenosis, occlusion, ischemia, elongation, compression, malapposition, invagination, revascularization, and rehospitalization.This article summarizes clinical outcomes of 32 patients that were treated with supera stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "clinical implications of the invagination of an interwoven nitinol stent: a single-center retrospective analysis.".

Manufacturer Narrative

B3, d6: dates estimated.B5: the patient deaths and device malfunctions referenced in b5 will be filed under separate medwatch report #s.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.A definitive cause for the reported stenosis, occlusion, and ischemia and the relationship to the product, if any, cannot be determined.The reported patient effects of stenosis, occlusion, and ischemia, are listed in the supera instructions for use (ifu) as known potential patient effects associated with the use of the device.The unexpected medical intervention and hospitalization were related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The udi is unknown as the part and lot numbers were not provided.Attachment - article title: clinical implications of the invagination of an interwoven nitinol stent: a single-center retrospective analysis.

• Brand Name: SUPERA
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11745188
• MDR Text Key: 247944587
• Report Number: 2024168-2021-03622
• 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
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Device Lot Number: UNKNOWN SUPERA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6F DESTINATION SHEATH; OPTICROSS 18 INTRAVASCULAR ULTRASOUND (IVUS) CATHE; 6F DESTINATION SHEATH; OPTICROSS 18 INTRAVASCULAR ULTRASOUND (IVUS) CATHE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR