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

Catalog Number 1013016-150

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis (2100)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.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 from this lot.The reported patient effect of thrombosis is listed in the absolute pro ll instruction for use as a known potential adverse event associated with the use of the device.The investigation was unable to determine a cause for the reported poor wall apposition and thrombosis.It may be possible that challenging anatomical conditions contributed to the difficulties; however, this could not be confirmed.The additional treatment was related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional 3 absolute pro devices referenced are filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was performed to treat a lesion with heavy calcification, heavy tortuosity, and 90% stenosis in the superior femoral artery.Reportedly, the patient had long segment occlusion from the superficial femoral opening to the adductor canal.An unspecified guide wire passed smoothly.Angiography showed no obvious blood flow after the progressive balloon pre-expansion, so the elastic retraction of the vessel was considered.A 6.0 x 150mm absolute stent was implanted in the lesion but the proximal portion of the stent had poor wall apposition.Repeated dilatation was performed with poor effects.A 6.0 x 100 mm absolute was attempted to be deployed but the release knob [thumbwheel] could not be rotated.The doctor used great force to release the stent with difficulty.Another 6.0 x 60 mm absolute stent was implanted, and the radiography showed that only a line of blood flow remained.A 6.0 x 40 mm absolute stent was then attempted to be implanted in the proximal opening; however, the difficulty to rotate the thumbwheel was felt but the stent was deployed completely, and the blood flow did not significantly improve.Dilatation was performed with an unspecified balloon.Final angiography showed that the stent distended in a good shape, but the blood flow was still not improved.The surgeon considered thrombosis of all four stents.There was no treatment administered for the thrombosis.There was no clinically significant delay in the procedure.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
• 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: 11314750
• MDR Text Key: 231400465
• Report Number: 2024168-2021-01116
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 1013016-150
• Device Lot Number: 9111361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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: GUIDE WIRE: 18 COMMAND; GUIDE WIRES: SUPRACORE, V18 BOSTON SCIENTIFIC; STENTS: 6.0X100, 6.0X60 AND 6.0X40 ABSOLUTE PROS
• Patient Outcome(s): Required Intervention