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 Failure to Advance (2524)

Patient Problems Myocardial Infarction (1969); Renal Failure (2041); Perforation of Vessels (2135); Stenosis (2263); Obstruction/Occlusion (2422); Respiratory Failure (2484); Vascular Dissection (3160); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 12/01/2020

Event Type  Injury  

Event Description

It was reported through the pmcf report, that the absolute pro.035 stent may be related to the adverse patient effects of death, myocardial infarction, pulmonary complications, renal complications, access site complications, thrombosis, embolization, dissection, perforation, occlusion, re-stenosis, revascularization, unplanned amputation / surgical intervention, re-hospitalization and the device malfunction of failure to cross.Details are listed in the attached report, titled post-market clinical follow-up evaluation report peripheral self-expanding stents please see the attached post market clinical follow up evaluation report for specific information.

Manufacturer Narrative

B3: date of event is estimated.D4: the udi is unknown due to the part/lot number was not provided.D6: date of implant is estimated.The device was not returned for evaluation.A review of the lot history record could not be conducted because the part and lot number was not provided.The investigation determined a conclusive cause for the reported failure to advance cannot be determined.The reported patient effect(s) of embolization, myocardial infarction, renal failure, restenosis, thrombosis, occlusion, vessel dissection, vessel perforation and surgical intervention are listed in the absolute pro vascular self-expanding stent system instructions for use as potential adverse effect (e.G., complications) that may be associated with the use of the device.A conclusive cause for the reported respiratory failure, renal failure, stenosis, embolism / embolus, vascular dissection, perforation of vessels, obstruction/ occlusion, thrombosis/ thrombus, myocardial infarction, unspecified tissue injury 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.The additional patient effect of death reported in the report is captured under separate medwatch report.As multiple devices were captured in the pmcf report, additional reports were filed under manufacturing reference numbers cn-164112.Pmcf attachment rpt2131801 rev c titled: post-market clinical follow-up evaluation report peripheral self-expanding stentsna.

• 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: 16811586
• MDR Text Key: 313988320
• Report Number: 2024168-2023-04313
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSOLUTE PRO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/25/2023
• 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): Disability; Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male