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

Catalog Number 1012015-150

Device Problems Break (1069); Entrapment of Device (1212); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It 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 performed to treat a lesion with moderate calcification and moderate tortuosity in the superior femoral artery.A 6f 40cm cross-over sheath was used.Pre-dilatation was performed with a non-abbott balloon.A 6.0 x 150 mm absolute pro self-expanding stent system was advanced to the target lesion, and resistance was felt with the non-abbott guide wire.Then after deploying about 1.5cm of the absolute pro stent, the thumbwheel could not be turned any further.It was decided to pull out the stent through the sheath, but the stent elongated and became stuck at arteriotomy site, resulting in tissue damage.As the physician did not want to damage the incision site any further, a vascular surgeon was called to perform a cutdown on the groin and repair the access site with a patch.The stent was successfully removed and the target lesion was ultimately treated.There was a delay in the procedure.No additional information was provided.

Manufacturer Narrative

H6: failure to follow steps / instructions.Visual, dimensional and functional analysis was performed on the returned device.The reported resistance with the guide wire, partial deployment, stretched stent, and thumbwheel jam was confirmed.The reported entrapment was unable to be confirmed as it was based on procedural circumstances.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 revealed no other complaints reported from this lot.It should be noted that the absolute pro ll peripheral self-expanding stent system utilizes a 0.035¿ (0.89 mm) guide wire as indicated on the product label and in the instruction for use (ifu).Additionally, the absolute pro ll instruction for use states: ¿use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.¿ the investigation determined that the reported difficulties were likely the result of using an undersized guide wire with the absolute pro ll stent system.It is likely that inadequate support for the shaft due to use of the undersized guide wire (0.018¿) caused the noted resistance during advancement and damage to the shaft lumens as noted on the returned unit.Additionally, during the attempt to deploy the stent, it is likely that restriction to the distal shaft lumens occurred in the anatomy (likely over the aortic bifurcation which was described as acute), preventing further movement of the shaft lumens and causing the thumbwheel to lock up resulting in partial deployment.Further attempts to rotate the thumbwheel against resistance likely caused the noted outer member separation within the handle at the distal end of the shuttle preventing any further transmission between the thumbwheel and retractable sheath.The damage noted to the returned absolute pro ll stent as well as the reported tissue damage likely occurred during the removal attempt with the partially deployed stent which ultimately required surgical intervention and a delay in the procedure.There is no indication of a product quality issue with respect to the design, manufacturer, or labeling of the device.

Event Description

Subsequent to the initially filed report, the following information was received: the stent strut was noted to be broken, but not separated into two pieces.It was confirmed that no portion of the device remains in the patient anatomy.No additional information was provided.

Event Description

Subsequent to the original filing, on (b)(6), 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.

Manufacturer Narrative

Visual, dimensional and functional analysis was performed on the returned device.The reported resistance with the guide wire, partial deployment, stretched stent, and thumbwheel jam was confirmed.The reported entrapment was unable to be confirmed as it was based on procedural circumstances.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 revealed no other complaints reported from this lot.It should be noted that the absolute pro ll peripheral self-expanding stent system utilizes a 0.035¿ (0.89 mm) guide wire as indicated on the product label and in the instruction for use (ifu).Additionally, the absolute pro ll instruction for use states: ¿use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.¿ in this event, use of an 0.018¿ guide wire likely contributed to the reported difficulties encountered.The investigation determined that the reported difficulties were likely the result of using an undersized guide wire with the absolute pro ll stent system as well as procedural circumstances.It is likely that inadequate support for the shaft due to use of the undersized guide wire (0.018¿) caused the noted resistance during advancement and damage to the shaft lumens as noted on the returned unit.Additionally, during the attempt to deploy the stent, it is likely that restriction to the distal shaft lumens occurred in the anatomy (likely over the aortic bifurcation which was described as acute), preventing further movement of the shaft lumens and causing the thumbwheel to lock up resulting in partial deployment.Further attempts to rotate the thumbwheel against resistance likely caused the noted outer member separation within the handle at the distal end of the shuttle preventing any further transmission between the thumbwheel and retractable sheath.The damage noted to the returned absolute pro ll stent as well as the reported tissue damage likely occurred during the removal attempt with the partially deployed stent which ultimately required surgical intervention and a delay in the procedure.Although the difficulties encountered appear to be related to procedural circumstances, on (b)(6) 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.

• 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: 11495659
• MDR Text Key: 240068109
• Report Number: 2024168-2021-02050
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 06/01/2022

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 1012015-150
• Device Lot Number: 0110462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 04/02/2021; 05/11/2022
• Supplement Dates FDA Received: 04/02/2021; 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2020
• 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 40CM CROSS-OVER SHEATH, V18 GUIDEWIRE; 6F 40CM CROSS-OVER SHEATH, V18 GUIDEWIRE
• Patient Outcome(s): Required Intervention