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

Model Number	1012537-100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the left external iliac artery.The 9.0x100mm absolute pro self-expanding stent system (sess) was successfully advanced to the target lesion and the stent was deployed with no issues.Post deployment, a mid stent fracture was observed.A 7.0x39 omnilink stent was successfully deployed to correct the stent fracture and remains in one piece.There was good flow.There was no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The udi is unknown due to the part/lot number was not provided.
Additional Manufacturer Narrative
The device was not returned for analysis.The reported break-stent was able to be confirmed via returned cine review.A review of the lot history record and similar incident review of the reported lot could not be conducted because the lot number was not provided.A cine was received and reviewed by an abbott vascular clinical specialist.In summary, the still frame images show a mid-stent fracture of the absolute pro 9 x100 mm with no probable cause and that a bail-out stent was successfully deployed resulting in acceptable patency of the external iliac artery.A device malfunction can be confirmed via the images provided.It is possible that interaction with the anatomy and/or other devices resulted in the reported stent break/fracture; however, this could not be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The treatment appears to be related to the operational context of the procedure as a 7.0x39 omnilink stent was successfully deployed to correct the stent fracture and remains in one piece.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 13112277
• Report Number: 2024168-2021-12260
• Device Sequence Number: 11883210
• Product Code: NIP
• UDI-Device Identifier: 08717648176258
• UDI-Public: 08717648176258
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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 Model Number: 1012537-100
• Device Catalogue Number: 1012537-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 64 KG