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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Pain (1994)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of pain and hypertension, as listed in the absolute pro instructions for use are known possible adverse events that may be associated with the use of the device.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported treatment with medications and hospitalization are due to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient was implanted with a 8.0x100mm absolute pro vascular self-expandable stent as well as another non-abbott balloon expandable covered stent in the upper right leg near abdomen.Patient began to experience pain in abdomen later on the same day.It was noted patient has been admitted to the hospital eight times ever since both stents were implanted and has been suffering from abdominal pain, hypertension, chest pain, leg pain on the right leg and recently neck pain.First time, the patient went to the emergency room (er) they were given antibiotics for their appendix; however; every other time the er doctors prescribed morphine and tramadol.The patient takes tylenol and motrin for the pain and clonidine for high blood pressure.An ultrasound was done in (b)(6) 2020, due to abdominal pain and no issue was found.Doctor is still monitoring the patient¿s appendix, but the patient is no longer having to take antibiotics.Patient is not sure what is causing the pain and last visit to the er was in (b)(6) 2020, but patient left before they were examined.No imaging was performed on the absolute pro stent.There was no clinically significant delay reported during the index procedure in december of 2019.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: 10877020
• Report Number: 2024168-2020-09784
• Device Sequence Number: 19595253
• Product Code: NIP
• UDI-Device Identifier: 08717648176173
• UDI-Public: 08717648176173
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 1012536-100
• Device Catalogue Number: 1012536-100
• Device Lot Number: 7102061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIFESTREAM BALLOON EXPANDABLE COVERED STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 70