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

Catalog Number 1012535-100

Device Problems Difficult to Remove (1528); Stretched (1601); Device Dislodged or Dislocated (2923); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat the sfa.The 7x100mm abs pro vascular self expanding stent system (sess) was advanced to the target lesion; however, during deployment of the stent the thumbwheel became stuck.The stent was noted to be partially deployed.Therefore, the sess was removed under fluoroscopy and the delivery system was removed; however, the stent became stuck during removal with a stent that had been implanted in a previous procedure and the stent became completely dislodged from the delivery system in the right common iliac.The dislodged stent was noted to appear very stretch.Therefore, ballooning and stent implantation was used to jail/embed the dislodged stent in the right common iliac.There was no adverse patient sequela.The procedure was completed with the implantation of 2 abs pro stents without issue at the target lesion.No additional information was provided.

Event Description

Subsequent to the previously filed report, initial information also reported that a.014 guidewire was used in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported mechanical jam and the reported activation failure were unable to be replicated in a testing environment due to the condition of the returned device.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.The reported device dislodged/dislocated was able to be confirmed.The reported stretched-stent was unable to be confirmed as the stent was deployed in the anatomy.The lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.Reportedly, the guidewire size used was a.014 guidewire.Use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.It should be noted the absolute pro vascular self-expanding stent system instructions for use (ifu) states to use one 0.035" (0.89 mm) diameter guide wire.The deviation of the ifu appears to have contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to deviation of the ifu and subsequent circumstances of the procedure as it is likely that during advancement use of the undersized.014¿ guide wire in conjunction with interaction with the high bifurcation approximately 70% near the target lesion resulted the noted device damages (indentations/kinks throughout the entire length of the stent holder, wrinkled sheath) such that during deployment prevented the shaft lumens from moving freely; thus resulting in the reported thumbwheel mechanical jam and the reported activation/deployment failure.Interaction with the previously implanted stent resulted in the reported difficult to remove.Interaction/manipulation of the compromised device during attempted removal resulted in the reported stretched stent and ultimately resulted in the reported stent dislodgement.As reported, ballooning and stent implantation was used to jail/embed the dislodged stent in the right common iliac.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 18935105
• MDR Text Key: 338067946
• Report Number: 2024168-2024-03494
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176098
• UDI-Public: 08717648176098
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012535-100
• Device Lot Number: 3041061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/10/2023
• 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: .014 GUIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Sex: Male