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

Catalog Number 1011919-060

Device Problems Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 10/25/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported mechanical jam and the reported activation failure were able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment sue 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 incidents from this lot.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 interaction with the introducer sheath resulted in the reported difficult to advance.During the second introduction/deployment attempt with the same device interaction with the heavily calcified anatomy resulted in preventing the shaft lumens from moving freely; thus resulting in the reported thumbwheel difficulties and the reported difficulty deploying the stent.Interaction/manipulation of the device resulted in the noted device damages (sheath separation, bent i-beam) contributing to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a heavily calcified lesion located in the left common iliac artery that was non tortuous.Access was straight up from the left groin up to the left common iliac artery occlusion.The 10.0/60mm on 80cm absolute pro self expanding stent system (sess) was advanced; however, resistance was noted with the introducer sheath.The sess was retracted and dilatation was performed.The sess was readvanced.An attempt was made to deploy the stent; however, heavy resistance was noted while turning the thumbwheel, and the stent completely failed to deploy.A new absolute pro sess was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis revealed the sheath was separated, approximately 7.5 millimeters (mm) distal to its proximal end.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: 18731480
• MDR Text Key: 335698963
• Report Number: 2024168-2024-02004
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011919-060
• Device Lot Number: 3090561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 90 KG