MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1011921-100

Device Problems Difficult to Flush (1251); Premature Activation (1484); Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/06/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a mildly calcified superficial femoral artery.The 6.0x100mm absolute pro self-expanding stent system (sess) was advanced and the stent was deployed.During removal of the sess, the stent caught on the shaft and the stent was stretched over 12 cm with the shaft.A second stent was needed to treat the target lesion.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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

Event Description

Subsequently, after the initial was filed it was reported that the stent was pulled back 12 cm remaining in the inferior portion of the femoral canal, but not stretched.Furthermore, during preparation of the stent it was noted there was difficulty felt when flushing the guide wire lumen and it was difficult to advance the stent over the wire.The sess was pulled back to flushed again; however, force was placed on the shaft, which moved the shaft and stent (premature deployment) before reinserting the stent.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to flush, the reported difficult to advance-guide wire and the reported difficult to remove-guide wire were unable to be confirmed.The reported premature activation was unable to be replicated in a testing environment due to the condition of the returned device.The reported migration-stent and the reported difficult to remove-stent unable to be replicated in a testing environment as they were based on operational 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 identified no other incidents from this lot.It is possible that inadvertent mishandling during unpacking and/or preparation for use resulted in the noted wrinkled sheath; thus resulting in the reported difficult to flush, the reported difficult to advance and the reported difficult to remove over the guide wire.The noted wrinkled sheath and/or manipulation of the device possibly compromised the device resulting in the reported premature activation; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficult to flush, difficult to advance-guide wire, difficult to remove-guide wire and the reported premature activation difficulties cannot be determined.Additionally, the investigation determined the reported difficult to remove and the reported stent migration appear to be related to circumstances of the procedure as during removal, it is likely that the tip/shaft of the device inadvertently got caught on the deployed stent resulting in the reported difficult to remove and ultimately resulted in the reported stent migration.The treatment appears to be related to the operational context of the procedure as a second stent was needed to treat the target lesion.Reportedly, during preparation of the stent it was noted there was difficulty felt when flushing the guide wire lumen and it was difficult to advance the stent over the wire.It should be noted the absolute pro ll peripheral self-expanding stent system instructions for use (ifu) states: do not use if the package is open or damaged, or if the product is damaged.Additionally, warnings section 5.0 states: should unusual resistance be felt at any time during lesion or stricture access or delivery system removal, the introducer sheath / guiding catheter and stent system should be removed as a single unit.Applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and delivery system components.It is undetermined if the deviation of the ifu caused/contributed to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code 1601 removed.

• Brand Name: ABSOLUTE PRO .035 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: 17262108
• MDR Text Key: 318441713
• Report Number: 2024168-2023-07078
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

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 Catalogue Number: 1011921-100
• Device Lot Number: 2121361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• 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): Required Intervention
• Patient Sex: Male