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

Catalog Number UNK ABSOLUTE PRO

Device Problems Difficult or Delayed Activation (2577); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number was not provided.As there was no damage noted to the device during the inspection prior to use, it is possible that during advancement interaction with the 90% stenosed anatomy resulted in preventing the shaft lumens from moving freely resulting in the reported thumbwheel difficulties and the reported difficulty deploying the stent; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The treatment appears to be related to the operational context of the procedure as reportedly the physician opened the handle and the stent was fully released.There is no indication of a product quality issue with respect to manufacture, design or labeling.D4: the udi is unknown due to the part/lot number was not provided.

Event Description

It was reported that the procedure was performed to treat a lesion in the lower extremities with 90% stenosis.The absolute pro self expanding stent system (sess) was attempted to be released; however, the thumbwheel wouldn't move.The stent completely would not deploy; therefore, the physician open the handle and the stent was fully released.There were no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.

• 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: 17655657
• MDR Text Key: 322360699
• Report Number: 2024168-2023-09528
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• 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): Other