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

Catalog Number	1012529-40
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual inspection and fourier transform infrared spectrometer analysis was performed on the returned device.The reported complaint was confirmed.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 of the reported lot revealed no other incidents.The investigation determined the loose material in the sealed header bag appears to be related to a potential product quality issue.The issue is being addressed per internal operation procedures.Abbott vascular will continue to trend the performance of these devices.
Event or Problem Description
It was reported that foreign material was noticed on the sterilization packaging of an 7.0x40 mm absolute pro vascular stent-expanding system (sess) during incoming inspection at (b)(4).The sterilization packaging was not opened, there was no damage to the inner pouch, and the sterility of the device was not compromised.The sess was not used.There was no patient involvement.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Device return analysis indicated that per chem analysis, colored foreign particle inside the sterile pouch near the manufacturing seal could not be identified but had some resemblance to types of thermoplastics such as peek and polysulfone.

• 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: 7873589
• Report Number: 2024168-2018-07150
• Device Sequence Number: 2049701
• Product Code: NIO
• UDI-Device Identifier: 08717648175626
• UDI-Public: 08717648175626
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 1012529-40
• Device Lot Number: 6061461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1