MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	S-55-120-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2018
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.Evaluation summary: visual inspection was performed on the returned device.The tip detachment was confirmed.It may be possible that the distal end of the introducer sheath was angled or bent such that during withdrawal, the supera tip caught on the edge of the sheath and separated; however, this could not be 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 revealed no other incidents reported from this lot.The investigation was unable to determine a cause for the reported tip separation.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 to treat the heavily calcified popliteal and superficial femoral arteries.Atherectomy was performed on the calcified arteries, followed by dilatation of the lesion.After balloon dilatation it was observed on angiography that further atherectomy was needed and was performed, which was followed by a short dilatation of the area.A dissection was observed at the distal end of the lesion due to the use of the atherectomy device.The supera stent delivery system was advanced without resistance felt and was deployed successfully for treatment.At that time, it was observed on angiography that the white tip of the catheter had separated.The supera stent delivery system was removed from the patient, but there were no attempts made to retrieve the separated tip.The patient underwent femoral distal bypass during which the tip was removed.No additional information was provided.

• Brand Name: SUPERA 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: 7325330
• Report Number: 2024168-2018-01674
• Device Sequence Number: 16169135
• Product Code: NIP
• UDI-Device Identifier: 08975370026320
• UDI-Public: 08975370026320
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2018

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: 06/30/2019
• Device Catalogue Number: S-55-120-120-P6
• Device Lot Number: 7072461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/08/2018
• 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: Hospitalization; Required Intervention; Disability
• Patient Age: 77 YR
• Patient Weight: 64