MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	1012529-40
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	06/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported stent migration and patient effects.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat the left iliac artery.A 7.0 x 40 mm absolute pro vascular self-expanding stent was implanted on (b)(6) 2015, and the patient was sent home that day.However, 30 minutes after the procedure was done, the patient felt a pop at the incision site.Three days later the patient began losing a significant amount of blood because the access site was cut during the procedure.The patient passed out and was re-hospitalized on (b)(6) 2015 to treat the blood loss.Yesterday, on (b)(6) 2017, the patient went to see her podiatrist because she has been experiencing a sharp pain in her leg since (b)(6) 2017, which turned a dark purple color.Her feet became colder, and her podiatrist could not get a pulse on either foot.The podiatrist stated that the stent implant may have moved or migrated from its location.The patient will see her physician to confirm her symptoms.The patient has not been taking any medication since their procedure.There was no additional adverse patient sequela reported.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6790270
• Report Number: 2024168-2017-06644
• Device Sequence Number: 878204
• Product Code: NIO
• UDI-Device Identifier: 08717648175626
• UDI-Public: 08717648175626
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

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 Catalogue Number: 1012529-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/11/2017
• 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: Disability