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

Catalog Number	1012531-60
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/23/2017
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 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.The reported patient effect of foreign body in patient is listed as a known patient effect that may be associated with use of a peripheral stent in native peripheral arteries.The investigation was unable to determine a conclusive cause for the reported difficulty and patient effect of foreign body in patient.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional absolute pro device referenced is being filed under a separate manufacturer report number.
Event or Problem Description
It was reported that on (b)(6) 2017, the procedure was to treat a lesion in the right external iliac artery.After positioning a 6fr non-abbott guiding sheath, a 7.0mm x 40mm x 135cm absolute pro vascular self-expanding stent system (sess) was advanced via the left common femoral artery, up and over to the target lesion in the right external iliac artery.The absolute pro stent was difficult to visualize under fluoroscopy and thought to be positioned in the target lesion; when releasing the stent, it was discovered that the proximal half of the stent had released inside of the guiding sheath.The sheath, guide wire, and partially deployed stent were withdrawn as a single unit, with resistance felt but no vessel damage noted.However, when reaching the left common femoral artery, the portion of the absolute pro stent that was protruding broke off / separated in the vessel.The separated stent portion was successfully surgically removed and treatment of the target lesion was rescheduled for (b)(6) 2017.The patient returned for treatment of the target lesion on 23 march 2017.A 9.0mm x 60mm x 80cm absolute pro vascular sess was advanced via the right common femoral artery.This absolute pro stent was also difficult to visualize under fluoroscopy and thought to be positioned in the target lesion.Thus, the stent was deployed, but it was discovered that the stent was deployed completely outside of the target lesion (partially in the abdominal aorta with the rest of the stent deployed in the common iliac).Another unspecified absolute pro sess was advanced without visibility issue and the stent was successfully deployed in the target lesion.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: 6476316
• Report Number: 2024168-2017-02965
• Device Sequence Number: 1289046
• Product Code: NIO
• UDI-Device Identifier: 08717648175794
• UDI-Public: (01)08717648175794(17)171031(10)4111461
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 1012531-60
• Device Lot Number: 4111461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/10/2017
• 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: Other