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

Catalog Number	S-55-150-120-P6
Health Effect - Clinical Codes	Pain (1994); Stenosis (2263); Diminished Pulse Pressure (2606)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of pain and stenosis are listed in the supera instructions for use as known patient effects of peripheral stenting procedures.Based on the case information and related record review, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The other two supera devices are filed under separate medwatch manufacturer report reference numbers.
Event or Problem Description
It was reported that on (b)(6) 2017,a supera stent was implanted in the right superficial artery (sfa) that was 100% stenosed.On (b)(6) 2017, a supera stent was implanted in the left superficial artery that was 95% stenosed.On (b)(6) 2017, the patient reported having severe pain in the left leg which made it very difficult to walk.On (b)(6) 2017, an additional supera stent and a non-abbott stent were implanted in the left sfa artery as it was noted through angiography that the previously implanted supera stent had become restenosed.After the procedure, the physician prescribed the patient with medication, which the patient continues to take presently.Initially, left leg pain was eliminated after the procedure on (b)(6) 2017.Minor pain emerged again in the left calf in (b)(6) 2018.During an arterial ultrasound on (b)(6) 2018, the physician confirmed that the pulse in the left ankle had weakened.Physician does not believe an additional intervention on the left leg is necessary.In (b)(6) 2018, the patient reported having very severe pain in her right calf and difficulty walking.Then on (b)(6) 2018, an arterial ultrasound was performed on the right leg because of increased pain and difficulty walking.The physician confirmed that the pulse in the right leg had weakened.Patient still experienced some pain in the right leg.On (b)(6) 2018 it was noted through angiography that the previously implanted right leg supera stent had become restenosed.After the procedure, the patient felt immediately better on the right leg.There was no adverse patient sequela reported.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: 7504845
• Report Number: 2024168-2018-03458
• Device Sequence Number: 1224398
• Product Code: NIP
• UDI-Device Identifier: 08975370026337
• UDI-Public: 08975370026337
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 7012761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/10/2018
• 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
• Patient Age: 62 YR
• Patient Weight: 70