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

Catalog Number 1011921-040

Device Problems Premature Activation (1484); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 2017 clarifier- against resistance.

Event Description

It was reported that the procedure was to treat a moderately calcified lesion in the right superior femoral artery (sfa).Pre-dilatation was successfully completed with an unspecified armada balloon and a 6.0x40mmx135cm absolute pro self-expanding stent system (sess) was attempted to be advanced into an introducer sheath when resistance was met.Force was applied and the sess was advanced, however, the stent became stuck in the hemostatic valve of the 6f non-abbott introducer sheath.An attempt was then made to remove the sess from the introducer sheath, and it could not be removed.The introducer sheath, guide wire (gw) and the absolute pro stent were removed as a single unit and another introducer sheath, guide wire and absolute pro stent were used to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to advance and the reported difficult to remove were able to be confirmed.The reported premature activation was unable to be replicated in a testing environment due to the condition of the returned device.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 from this lot.Reportedly, the 6.0x40mmx135cm absolute pro self-expanding stent system (sess) was attempted to be advanced into an introducer sheath when resistance was met.Force was applied and the sess was advanced, however, the stent became stuck in the hemostatic valve of the 6f non-abbott introducer sheath.An attempt was then made to remove the sess from the introducer sheath, and it could not be removed.It should be noted the absolute pro.035 peripheral self-expanding stent system instructions for use 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.The deviation of the instructions for use appears to have caused/contributed to the reported difficulties.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction with the guide wire introducer sheath resulted in the reported difficult to advance.Manipulation of the device using force resulted in the noted multiple device damages compromising the device; thus resulting in the device becoming stuck in the hemostatic valve (reported difficult to remove) and ultimately resulting in the reported premature activation.The noted unknown clear material on the damaged device are likely artifacts from the compromised devices.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed report, additional information was received that when the device was retrieved, the stent was exposed.No additional information was provided.

Manufacturer Narrative

As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction with the guide wire introducer sheath resulted in the reported difficult to advance.Manipulation of the device resulted in the noted multiple device damages compromising the device; thus resulting in the device becoming stuck in the hemostatic valve (reported difficult to remove) and ultimately resulting in the reported premature activation.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: code 2017 was removed.

Event Description

Subsequent to the previously filed report, additional information was received.The account stated that no force was applied when resistance was felt as initially reported.No additional information was provided.

• 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: 17262372
• MDR Text Key: 318611419
• Report Number: 2024168-2023-07073
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011921-040
• Device Lot Number: 2072661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2022
• 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
• Treatment: 6F FLEXOR INTRODUCER FROM COOK.
• Patient Age: 75 YR
• Patient Sex: Male