MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number UNK ABSOLUTE PRO

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

Patient Problems Intimal Dissection (1333); Pulmonary Embolism (1498); Arrhythmia (1721); Embolism (1829); Fistula (1862); Hematoma (1884); Unspecified Infection (1930); Myocardial Infarction (1969); Occlusion (1984); Perforation (2001); Thrombosis (2100); Heart Failure (2206); Stenosis (2263); Claudication (2550); Pseudoaneurysm (2605); Test Result (2695)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated date of event.The udi is unknown because the part and lot numbers were not provided.Date of implant: estimated date of implant.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.The reported patient effects of embolization, perforation, dissection, occlusion, thrombosis, pulmonary embolism, arrhythmia, pseudoaneurysm, claudication, hematoma, fistula, restenosis, infection and surgery are listed in the absolute pro instruction for use as known potential patient effects that may be associated with the use of the device.Based on the case information, a conclusive cause for the reported embolization, perforation, dissection, occlusion, thrombosis, pulmonary embolism, arrhythmia, pseudoaneurysm, claudication, hematoma, fistula, restenosis, infection, myocardial infarction (mi), heart failure and abnormal test results, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature article title: "absolute pro pmcf report".The additional deaths referenced are being filed under a separate medwatch report.

Event Description

It was reported through a study report identifying that absolute pro stents may be related to the following: death, myocardial infarction, thrombosis, embolization, dissection, occlusion, perforation, amputation, creatine increase, pulmonary embolism, ventilator support, pneumonia, cardiac dysrhythmia, congestive heart failure, pseudoaneurysm, hematoma, av fistula, stenosis, claudication, revascularization, surgical intervention, and rehospitalization.This article summarizes clinical outcomes of 1,149 patients that were treated with absolute pro stents.Specific patient information is documented as unknown.Details are listed in the article, titled "absolute pro pmcf report.".

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10587070
• MDR Text Key: 208552869
• Report Number: 2024168-2020-08008
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSOLUTE PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Disability