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); Product Quality Problem (1506); Difficult to Remove (1528); Material Separation (1562); Mechanical Jam (2983); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the iliac artery.During deployment, the thumbwheel of the absolute pro stent delivery system stopped turning and the stent ruptured.An attempt was made to break the stent delivery system handle in an attempt to release the stent; however, this failed and the stent remained in the proximal iliac artery.A non-abbott stent was then implanted without issue.No additional information was provided.

Event Description

Subsequent to the initial 30-day med-watch report, the following information was provided: difficulty was noted during deployment of the absolute pro stent.The thumbwheel stopped turning and the stent delivery system separated, not the stent.In order to release the stent, the delivery system handle was broken, allowing stent deployment.Resistance was noted during removal of the delivery system.A second non-abbott stent was implanted to fully cover the target lesion.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported deployment issue, thumbwheel jam and shaft separation were confirmed.The difficulty removing was unable to be confirmed due to the condition of the returned unit.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 complaints.The investigation was unable to determine a definitive cause for the difficulties.It may be possible that the distal shaft was bent or entrapped within the anatomy, preventing movement of the shaft lumens and causing the thumbwheel to lock up.The kinks noted sporadically throughout the entire length of the retractable sheath further suggest that the distal sheath was bent, possibly over the iliac bifurcation.The separations likely occurred due to continued attempts to rotate the thumbwheel against resistance exceeding the tensile strength.Once the shaft separated, it is likely that the ribbon recoiled and spooled around the center handle pin.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Device code 1069 removed.

Manufacturer Narrative

The investigation was unable to determine a definitive cause for the difficulties.It may be possible that the distal shaft was bent or restricted over the iliac bifurcation preventing the shaft lumens from moving freely and causing the thumbwheel to lock up.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to follow-up #1 medwatch report, the following additional information was provided: this was a femoral to femoral crossover procedure, in which the absolute pro stent delivery system was advanced from one femoral artery over to the mildly calcified target lesion in the other femoral artery and iliac artery.No additional information was provided.

Manufacturer Narrative

The reported difficulty of friction, caused by the angulation, making the system heat up was likely the result of the distal shaft being kinked or entrapped with the anatomy preventing movement of the shaft lumens.Continued force likely caused the outer member to separate.The additional treatment was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the supplemental report, the following additional information was reported: reportedly, during the cross-over procedure, due to the sharp angulation of the aorto-iliac carina, the physician was able to turn the thumbwheel too quickly, resulting in friction and heat in the delivery catheter.Resistance was noted when turning the thumbwheel, and the thumbwheel stopped turning.The stent delivery system broke as a result of the friction and heat, as well as the length of the lesion and vessel tortuosity.No additional information was provided.

• 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
• MDR Report Key: 9672499
• MDR Text Key: 177958032
• Report Number: 2024168-2020-01221
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 1012015-150
• Device Lot Number: 9101561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention