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

Model Number	1012538-40
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2020
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported that during a left subclavian artery stenting procedure, the absolute pro stent system was advanced to the lesion without issue; however, during stent deployment, the stent jumped into the aorta.The stent was snared and removed.There was no adverse patient sequela or a clinically significant delay in procedure.Another same size absolute pro stent was successfully deployed and implanted to complete the procedure.No additional information regarding this issue was provided.
Additional Manufacturer Narrative
Only the stent was returned to abbott vascular for analysis.Visual analysis was performed on the returned device.The reported malposition of the device could not be confirmed.There were fractured struts in the distal and proximal end of the stent implant.The entire stent implant was stretched out and bent.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.Based on the information provided, the investigation was unable to determine a conclusive cause for the reported malposition.It may be possible that the delivery system interaction with the anatomy prevented smooth deployment causing the stent to jump forward under the retraction force of the deployment sheath, however, this could not be confirmed.The removal of the foreign body is due to the case circumstances.The noted material separation and deformation are due to case circumstances.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
• MDR Report Key: 11152461
• Report Number: 2024168-2021-00323
• Device Sequence Number: 3878853
• Product Code: NIP
• UDI-Device Identifier: 08717648176289
• UDI-Public: 08717648176289
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: 10/31/2022
• Device Model Number: 1012538-40
• Device Catalogue Number: 1012538-40
• Device Lot Number: 9112561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention