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

Catalog Number 1012017-150

Device Problems Break (1069); Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat the superficial femoral artery with moderate calcification and moderate tortuosity.Pre-dilatation was performed with a 5x150 mm armada 35 percutaneous transluminal angioplasty (pta) catheter.The 5x150 mm absolute pro self expanding stent system (sess) was prepared per the instructions for use and then during deployment, the thumb wheel got stuck and was not moving forward.Therefore, the partially deployed stent and sess were removed slowly with resistance into the sheath and the complete system was taken out.During this part of the procedure, part of the iliac artery became dissected.An 8x40 mm absolute pro stent was implanted to treat the dissection.There were no reported adverse patient sequela and there was no reported clinically significant delay in the procedure.An 8x150 mm absolute pro sess which had not been previously reported was received by the returned goods lab with a separated tip, kinks and the stent was not returned.The account was not aware of the separation and the stent was implanted successfully without issue or patient effects; however as the tip cannot be located there is the potential it remains in the patient.No additional information was provided.

Event Description

It was reported that the procedure was to treat the superficial femoral artery with moderate calcification and moderate tortuosity.Pre-dilatation was performed with a 5x100 mm armada 35 percutaneous transluminal angioplasty (pta) catheter.The 5x100 mm absolute pro self expanding stent system (sess) was prepared per the instructions for use and then during deployment, the thumb wheel got stuck and was not moving forward.Therefore, the partially deployed stent and sess were removed slowly with resistance into the sheath and the complete system was taken out.During this part of the procedure, part of the iliac artery became dissected.An 8x40 mm absolute pro stent was implanted to treat the dissection.There were no reported adverse patient sequela and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the first absolute pro sess used was a 5x150 mm absolute pro sess and not a 5x100.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a similar incident review for this product was not performed because there was no devices issues reported.As reported, the stent was implanted successfully without issue or patient effects and the account was not aware of the separation, it is possible that the reported foreign body in patient (tip separation) and the noted multiple device damages occurred due to handling post procedure or during packing for return analysis; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.B1: product problem removed b5: size of first absolute pro sess used updated h6: medical device problem codes 1562 and 1069 removed.

• Brand Name: ABSOLUTE PRO LL 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: 13476517
• MDR Text Key: 288279466
• Report Number: 2024168-2022-01249
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 1012017-150
• Device Lot Number: 0110561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2020
• 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