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

Catalog Number	S-55-060-120-P6
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	02/19/2018
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 and complaint history of the reported lot could not be conducted since the lot number was not provided.The reported patient effect of stenosis is listed in the instructions for use supera peripheral stent systems as a known patient effects of the stenting procedure.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 manufacture, design or labeling.
Event or Problem Description
It was reported that the index procedure took place on (b)(6) 2018 during which a 5.5 x 60 mm supera stent was implanted to open the right popliteal artery.The patient was readmitted to the hospital on (b)(6) 2018 for an occlusion of the left popliteal artery, and in-stent restenosis of the right popliteal artery, where the 5.5 x 60 mm supera stent was implanted.Revascularization was done to treat the occlusion in the left popliteal artery which included performing laser therapy, dilating the lesion with an unspecified balloon dilatation catheter (bdc) and implanting three unspecified supera stents.Revascularization was also done to treat the in-stent restenosis of the right popliteal artery which included performing laser therapy and dilating the lesion with an unspecified bdc.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: 7339762
• Report Number: 2024168-2018-01835
• Device Sequence Number: 13758339
• Product Code: NIP
• UDI-Device Identifier: 08975370026290
• UDI-Public: 08975370026290
• 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): 03/14/2018

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 Catalogue Number: S-55-060-120-P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/14/2018
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 70