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

Catalog Number 1012017-150

Device Problems Mechanical Jam (2983); Activation Failure (3270)

Patient Problems Foreign Body In Patient (2687); Vascular Dissection (3160)

Event Date 01/03/2023

Event Type  Injury  

Event Description

It was reported that the procedure was performed to treat a lesion in the left common femoral artery (cfa) with moderate calcification and moderate tortuosity.The lesion was crossed with a non-abbott wire.After pre dilating the lesion with a 8x60mm armada 35 percutaneous transluminal angioplasty (pta) catheter, the 8x150mm absolute pro ll self expanding stent system (sess) crossed the lesion.However, the stent only partially deployed since the thumbwheel stopped rotating.A crossover, long sheath was advanced over the stent to take the stent inside the sheath to be removed.There was a vessel dissection which was not treated and the patient was put on medical management.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

The device was returned for analysis.The reported activation failure and the reported mechanical jam were able to be confirmed.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.The reported patient effect(s) of dissection is listed in the absolute pro ll peripheral self-expanding stent system instructions for use as a possible complication.It is possible that the distal shaft was bent by the moderately calcified and moderate torturous anatomy preventing the shaft lumens from moving freely, resulting in resistance with the thumbwheel and difficulty deploying the stent; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted activation failure and mechanical jam cannot be determined.Manipulation of the device likely resulted in the noted multiple device damages.The reported difficulties possibly caused/contributed to the reported patient effect(s); however conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The treatment(s) appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial filed report, the device was returned and the sheath was torn and there were separated stent struts.It was unable to be determined if any portions of the sheath had separated.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: 16286086
• MDR Text Key: 308668223
• Report Number: 2024168-2023-01103
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110028
• 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
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012017-150
• Device Lot Number: 1071561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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: TERUMO RADIFOCUS 0.035'' WIRE
• Patient Outcome(s): Required Intervention