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

Model Number	1012536-30
Medical Device Problem Codes	Defective Device (2588); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.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 the procedure was to treat a lesion located in the left external iliac artery.An 8 x 30 x 135 cm absolute pro vascular stent was deployed in the left external iliac.There were no complications with deployment.The lesion was post dilated with an 8 x 40 balloon, and the balloon was the same length as the stent.The balloon was measured against other 40 mm balloons that had been utilized to prep the lesion, and it was the correct length.Based on this, it was felt that the stent was longer than it¿s labeled length.There was no adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional inspection was performed on the returned device.The stent remains implanted and was not returned.The reported device marking / labeling problem and defective device was not confirmed as the stent was not returned.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 similar incidents from this lot.Possible factors that may contribute to device markings/labelling problem (device) and defective device (oversized) include but are not limited to, mislabeled packaging, incorrect stent size loaded in the delivery system during manufacturing, deployment difficulties, anatomical conditions, angle of the imaging, or use technique.The investigation was unable to determine a conclusive cause for the reported complaint.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSOLUTE PRO VASCULAR
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9950350
• Report Number: 2024168-2020-03574
• Device Sequence Number: 3320146
• Product Code: NIP
• UDI-Device Identifier: 08717648176135
• UDI-Public: 08717648176135
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: 09/30/2021
• Device Model Number: 1012536-30
• Device Catalogue Number: 1012536-30
• Device Lot Number: 8101661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR