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

Model Number 1012534-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2020

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.Based on the case information, the reported additional therapy/non-surgical treatment and treatment with medications were due to case circumstances.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 the right distal superficial femoral artery (sfa)/proximal popliteal occlusion.A 6.0x40mm absolute pro self-expanding stent was advanced and deployed; however, due to the support wire being inserted into the wrong vessel 1mm of the distal end of the stent was placed in the collateral vessel.It was attempted to retrieve/reposition the stent through balloon manipulation but was not possible.The stent wall was blocking the desired guide wire path.Due to this, the physician was unable to pass a wire through the stent struts as the femoral artery/popliteal was occluded (target lesion) at this section as well, making crossing the lesion more challenging.The collateral vessel remained patent and it was decided to treat the patient with medical management with the option to bypass at a later time.No adverse patient effect or clinically significant delay was reported.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR 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: 10959295
• MDR Text Key: 219906809
• Report Number: 2024168-2020-10206
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648175985
• UDI-Public: 08717648175985
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 1012534-40
• Device Catalogue Number: 1012534-40
• Device Lot Number: 0060461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• 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