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

Catalog Number	S-65-150-120-P6
Health Effect - Clinical Codes	Stenosis (2263); Claudication (2550)
Date of Event	03/20/2017
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.Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned as the stent remains in the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the case information and related record review, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The reported patient effects of claudication and stenosis are listed in the supera instructions for use (ifu) as known patient effects of peripheral stenting procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2016, a 6.5x150x120cm 6f supera peripheral stent was successfully deployed in a 90mm-long lesion in the right superficial femoral artery (sfa).On (b)(6) 2017, the patient presented with claudication and an angiogram revealed in-stent restenosis (isr) of the supera stent.The isr and claudication were successfully resolved via atherectomy and angioplasty with an unspecified 7.0x150mm balloon.There were no adverse patient sequelae.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: 6476011
• Report Number: 2024168-2017-02955
• Device Sequence Number: 332952
• Product Code: NIP
• UDI-Device Identifier: 08975370026399
• UDI-Public: (01)08975370026399(17)160630(10)02368070
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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: 06/30/2016
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 02368070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 04/10/2017
• 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: 61 YR
• Patient Weight: 107