MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA PERIPHERAL STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number	S-60-080-120-P6
Medical Device Problem Codes	Product Quality Problem (1506); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Exemption number e2019001.
Event or Problem Description
It was reported that the distribution center was performing inspections on supera peripheral self-expanding stent systems (sess).The position of the flush port of a 6.0 x 80 supera sess was abnormal, and the tyvek pouches of a 6.5 x 40 cm and a 6.5 x 80 cm supera sess were defected.There was no patient involvement and no reported clinically significant delay in the procedure.No additional information was provided.Device analysis revealed that there was an unknown material at the proximal end of the sheath flush port of the 6.0x80 supera.
Additional Manufacturer Narrative
Exemption number e2019001.Product performance engineering reviewed the complaint information and analysis of the returned unit.Visual and dimensional inspection was performed.The reported irregular position of the flush port was not confirmed.However, foreign material was observed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.The investigation determined the foreign material inside the unopened pouch appears to be related to a potential product quality issue.An exception has been initiated due to the potential product quality issue and corrective action, if any, will be determined per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: SUPERA PERIPHERAL 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: 9192539
• Report Number: 2024168-2019-12614
• Device Sequence Number: 13913344
• Product Code: NIP
• UDI-Device Identifier: 08717648211812
• UDI-Public: 08717648211812
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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: 01/31/2021
• Device Catalogue Number: S-60-080-120-P6
• Device Lot Number: 9022161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1