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 Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat restenosis in the right superficial femoral artery (sfa) that was 20% stenosed.The distal side of the sfa was pre-dilated with a 6 x 130 mm non-abbott balloon dilatation catheter.A 6.5 x 150 mm supera stent was deployed from the middle to the distal side of the sfa.Per the physician, the deployment was completed smoothly.During removal of the delivery system, it was noted that the stent had been partially deployed in the guiding catheter.It was confirmed via cineangiography that while moving the guiding catheter, the stent moved proximal from the target area.The stent and delivery system were retrieve with the guiding catheter as a single unit.A 7 x 120 mm and a 7 x 80 mm non-abbott stents were successfully deployed to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned unit.The reported partial deployment was not confirmed due to the condition of the returned unit.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 complaints.The investigation determined that the difficulties appear to be due to procedural related circumstances.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 restenosis in the right superficial femoral artery (sfa) that was 20% stenosed.The distal side of the sfa was pre-dilated with a 6x130mm non-abbott balloon dilatation catheter.A 6.5x150mm supera stent was deployed from the middle to the distal side of the sfa.Per the physician, the deployment was completed smoothly.During removal of the delivery system, it was noted that the stent had been partially deployed in the guiding catheter.It was confirmed via cineangiography that while moving the guiding catheter, the stent moved proximal from the target area.The stent and delivery system were retrieve with the guiding catheter as a single unit.A 7x120mm and a 7x80mm non-abbott stents were successfully deployed to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 9105602
• Report Number: 2024168-2019-11987
• Device Sequence Number: 11243820
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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: 02/28/2021
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 9031461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR11CM XEMEX; GUIDEWIRE-V18/BOSTON