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

Model Number	1012538-100
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar complaints.The investigation was unable to determine a cause for the reported premature deployment.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left common iliac artery.A 10x100mm absolute pro vascular self-expanding stent system (sess) was being advanced when the stent deployed prematurely in an unintended site without initiating deployment.A cut down was performed to remove the stent, and the procedure was aborted.There were no adverse patient sequelae, but there was a clinically significant delay in the procedure.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
• MDR Report Key: 10332273
• Report Number: 2024168-2020-06229
• Device Sequence Number: 16398953
• Product Code: NIP
• UDI-Device Identifier: 08717648176319
• UDI-Public: 08717648176319
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2020

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: 01/31/2023
• Device Model Number: 1012538-100
• Device Catalogue Number: 1012538-100
• Device Lot Number: 0020461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/28/2020
• 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
• Patient Age: 80 YR
• Patient Weight: 73