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

Catalog Number	S-65-150-120-P6
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.Visual inspection was performed.The reported crack/break was not confirmed.A piece of the strain relief material was separated at the distal end of the of the strain relief was noted.The separated portion of the strain relief appears to have potentially originated from the molded component supplier.However this defect is cosmetic and nature and would not affect the performance of the device.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed two other incidents for a crack/break.The investigation was unable to determine a conclusive cause for the reported issue.Based on the information reviewed however, a potential product quality has been identified.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.The two additional supera devices referenced are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that during inspection at century medical inc.It was noted that three supera devices (6.5x150mm) were noted to have a crack on the product.The devices were not used.No additional information was provided.The return device analysis for all three 6.5x150mm superas identified that a piece of the strain relief material was separated at the distal end of the of the strain relief.

• 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: 9225169
• Report Number: 2024168-2019-12855
• Device Sequence Number: 2132161
• Product Code: NIP
• UDI-Device Identifier: 08717648226328
• UDI-Public: 08717648226328
• 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
• Report Date (Section B): 10/23/2019

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: 11/30/2020
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 8121261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1