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

Catalog Number	1012535-40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
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 analysis.Post-procedure photos of the implanted stent were returned and reviewed by an abbott clinical specialist.The reviewer concluded the following: the absolute pro stent image provided does appear to show a discontinuity within the stent pattern at roughly the middle section of the stent.Unfortunately, the imaging detail is not sufficient to confirm an actual separation of the stent cut pattern.Due to the heavy calcification in the vessel, there is likely some substantial influence on the stent pattern which could be what is appearing to be considered a fracture.Without additional higher detailed imaging, the confirmation of a fracture is unclear.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the complaint handling database revealed no other similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported stent fracture.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the right external iliac artery.A 7.0x40mm absolute pro vascular self-expanding stent system was advanced to the target lesion and deployed without issue.Angiography after deployment revealed that the stent was fractured.The stent was post-dilated with an unspecified balloon dilatation catheter, and a 7.0x30mm absolute pro vascular stent was then deployed to cover the stent fracture.There was no adverse patient effect and no reported 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 STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7907049
• Report Number: 2024168-2018-07374
• Device Sequence Number: 11144645
• Product Code: NIO
• UDI-Device Identifier: 08717648176067
• UDI-Public: 08717648176067
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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: 10/31/2020
• Device Catalogue Number: 1012535-40
• Device Lot Number: 7112961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/25/2018
• 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: 73 YR
• Patient Weight: 66