MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA PERIPHERAL STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number	S-65-040-120-P6
Medical Device Problem Codes	Device Damaged by Another Device (2915); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/29/2019
Type of Reportable Event	Serious Injury
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 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.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.Based on the information provided, the reported difficulties appear to be due to operational circumstances of the procedure.The stent migration was the result of interaction with the introducer sheath.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 on (b)(6) 2019, the patient underwent a peripheral procedure, with implantation of a 6.5 x 40 mm supera stent in the right common femoral artery.On (b)(6) 2019, the patient underwent a coronary angiography, for percutaneous coronary intervention.A 4 french (fr) system was used for the coronary angiography; however, the sheath was replaced with a 6fr sheath and inserted, without the physician checking placement on imaging.The 6fr sheath interacted with the implanted supera stent, pushing the stent from the right common femoral artery into the external iliac artery.There were no issues noted with blood flow; therefore, no additional intervention was performed.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: 9132270
• Report Number: 2024168-2019-12182
• Device Sequence Number: 16600623
• Product Code: NIP
• UDI-Device Identifier: 08717648226229
• UDI-Public: 08717648226229
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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: 12/31/2020
• Device Catalogue Number: S-65-040-120-P6
• Device Lot Number: 9012561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 09/27/2019
• 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: Other