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

Model Number	1012536-100
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the 8.0x100mm absolute pro was removed from packaging without any issues.It was then noted that the stent was partially deployed (not flowered).The device was not used.A new absolute pro was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported premature activation was confirmed.There was noted wrinkles and irregular appearance likely caused by handling.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 reported from this lot.Based on the information provided, the reported difficulties appear to be due to operational circumstances of the procedure.It is likely that during removal of the stylet, the tip was inadvertently pulled such that the stent slightly pulled out and flowered.It may also be likely that the stylet was not removed per the instructions for use (ifu).The delivery system preparation section of the absolute pro.035 biliary self-expanding stent system ifu instructs: ¿gently twist and pull to remove the tip mandrel.If the tip mandrel is not easily removed, do not use the device." the noted wrinkles and irregular appearance likely were caused by handling.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.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: 11674386
• Report Number: 2024168-2021-03176
• Device Sequence Number: 4356979
• Product Code: NIP
• UDI-Device Identifier: 08717648176173
• UDI-Public: 08717648176173
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1012536-100
• Device Catalogue Number: 1012536-100
• Device Lot Number: 9090361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 04/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1