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

Model Number	1012537-40
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Additional 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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the mildly calcified anatomy resulting in the reported difficult to advance.Additionally, the distal shaft was likely bent in the mildly calcified and steep aortic bifurcated anatomy preventing the shaft lumens from moving freely, thus resulting in resistance with the thumbwheel and the difficulty deploying the stent.Resistance with the steep aortic bifurcated anatomy resulted in the reported difficult to remove.Interaction with the sheath resulted in the reported difficult to remove and ultimately resulted in the reported stent dislodgement/reported foreign body in patient.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that on (b)(6) 2022, a percutaneous peripheral intervention was performed on the right common iliac artery, mildly calcified lesion.An absolute pro vascular stent delivery system (sds) advanced with difficulty due to the steep aortic bifurcation.Once at the right common iliac, deployment was attempted, however, the thumbwheel was difficult to turn and then stopped turning.The stent had only partially deployed.Standard troubleshooting was performed, retracting the sheath, however the issue remained.During sds removal, the device was difficult to remove due to the steep bifurcation and difficult to retract the stent into the non-abbott sheath.During removal attempt, the non-abbott outer sheath had separated, requiring snare for removal, and the partially deployed stent had dislodged.The partially deployed stent deployed fully at an unintended area, in the left common iliac artery.It was decided to leave the fully deployed stent at this location.A non-abbott stent was successfully implanted in the right common iliac artery.There was no adverse patient sequela, and there was no clinically significant delay reported.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: 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: 14213190
• Report Number: 2024168-2022-04506
• Device Sequence Number: 4309980
• Product Code: NIP
• UDI-Device Identifier: 08717648176227
• UDI-Public: 08717648176227
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 1012537-40
• Device Catalogue Number: 1012537-40
• Device Lot Number: 9041061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 74 KG