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

Catalog Number 1012014-150

Device Problems Material Separation (1562); Difficult to Advance (2920); Material Deformation (2976); Mechanical Jam (2983); Activation Failure (3270); Noise, Audible (3273)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

The device is returning for analysis but has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a highly calcified occluded right superficial femoral artery.The 6f introducer sheath was inserted with some difficulty due to the tight bifurcation.Then a 5x150mm absolute pro ll was advanced to the lesion, with difficulty due to anatomy.Once deployment initiated, only around 5cm of the stent partially deployed and the thumbwheel was only able to turn 4-5 times before being unable to turn further and hearing a sound of the absolute pro delivery system breaking.The whole system with the partially deployed stent was able to be removed via a long 6f introducer.Once removed, it was unable to be confirmed that the delivery system was broken but it was noted that the stent implant was damaged.Two other absolute pro stents (5x60x135 and 5x150x135) were used to successfully treat the lesion.The physician believes the device broke due to the tight bifurcation, although visually they were unable to confirm it.However, the physician remains uncertain if all of the device was retrieved fully or if a broken piece remains in the patient.A scan was not performed to check for remaining device parts in the anatomy.The patient is doing fine.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

Event Description

It was reported that the procedure was to treat a highly calcified occluded right superficial femoral artery.The 6f introducer sheath was inserted with some difficulty due to the tight bifurcation.Then a 5x150mm absolute pro ll was advanced to the lesion, with difficulty due to anatomy.Once deployment initiated, only around 5cm of the stent partially deployed and the thumbwheel was only able to turn 4-5 times before being unable to turn further and hearing a sound of the absolute pro delivery system breaking.The whole system with the partially deployed stent was able to be removed via a long 6f introducer.Once removed, it was unable to be confirmed that the delivery system was broken but it was noted that the stent implant was damaged.Two other absolute pro stents (5x60x135 and 5x150x135) were used to successfully treat the lesion.The physician believes the device broke due to the tight bifurcation, although visually they were unable to confirm it.However, the physician remains uncertain if all of the device was retrieved fully or if a broken piece remains in the patient.A scan was not performed to check for remaining device parts in the anatomy.The patient is doing fine.There was no adverse patient sequela and no clinically significant delay.Subsequent to the initially filed mdr report, return device analysis confirmed there was no separation; therefore it is confirmed that nothing remains in the patient.

Manufacturer Narrative

A visual and functional analysis was performed on the returned device.The activation failure, mechanical jam, noise, and material deformation were confirmed.The difficulty to advance and material separation were not confirmed.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 review of the complaint history identified no other similar incidents.Based on the information provided, the investigation determined the reported difficulties were due to the circumstances of the procedure.In this case, based on the reported information, it is likely that the anatomical conditions of the tight bifurcation and of the highly calcified occluded vessel induced a constriction and damage in the shaft sheath during the insertion process or during the activation, causing resistance with the thumbwheel, and partial deployment.The noise would likely have resulted from the handle separating while attempting to turn the thumbwheel after it became stuck; causing the internal mechanism to become dislocated.The additional damage to the stent was most likely caused during the removal of the system from the anatomy.The return goods analysis confirmed there was no separation noted on the sess, and therefore no foreign body left in the patient.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B1,b2, h1: type of reportable event changed from serious injury to malfunction.Patient code 2687 removed and 2199 added.

Manufacturer Narrative

Although the difficulties encountered appear to be related to procedural circumstances, on may 11th, 2022, abbott determined that a field safety notice (fsn) was required for the absolute pro ll peripheral self-expanding stent system (psess).Abbott has confirmed reports of mechanical locking, stent deployment and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent.To reduce occurrences of deployment failures and associated outcomes, abbott is notifying all users of the potential causes and risks.

Event Description

Subsequent to the original filing, on may 11th, 2022, abbott determined that a field safety notice was required for the absolute pro ll peripheral self-expanding stent system (psess).Abbott has confirmed reports of mechanical locking, stent deployment and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent.To reduce occurrences of deployment failures and associated outcomes, abbott is notifying all users of the potential causes and risks.

• 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: 11657231
• MDR Text Key: 245150625
• Report Number: 2024168-2021-03068
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 1012014-150
• Device Lot Number: 0091461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• 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
• Treatment: 6F INTRODUCER; ZIPWIRE STIFF 260, BOSTON SCIENTIFIC.; 6F INTRODUCER; ZIPWIRE STIFF 260, BOSTON SCIENTIFIC.
• Patient Outcome(s): Other