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

Model Number	S-65-040-120-P6
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Defective Device (2588); Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional device referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat the proximal to mid superficial femoral artery.The vessel diameter was 6.3 mm and atherectomy was not performed.Pre-dilatation was performed with a 6x40 mm non-abbott balloon for 120 seconds at 24 atmospheres twice.The 6.5x40 mm supera self expanding stent system (sess) was advanced to the lesion and deployed; however, the stent began to shorten and slip out of place from the target lesion during deployment.Some of the stent went into healthy tissue while some remained in the target lesion.The physician stated it was possible the stent moved during deployment.Next, a 6.5x80 mm supera sess was advanced and was deployed.However, the stent elongated when the delivery system was removed and some went into healthy tissue, while some remained in the target lesion.It was attempted to retrieve the stent using a non-abbott sheath but the delivery system was stuck completely and failed to remove all of the stent and delivery system.The tip of the supera is damaged.Surgery was performed to retrieve the delivery system, stent and the first implanted stent as well.Final patient outcome is good.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.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 incidents from this lot.It is possible that during stent deployment interaction with the anatomy and/or the delivery system was slightly pushed distally as the stent was being deployed resulting in the stent to shorten and slip out of place from the target lesion; thus resulting in the reported stent migration and stent malposition into healthy tissue; however, this could not be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.The treatment appears to be related to the operational context of the procedure as surgery was performed to retrieve the implanted stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9/h3 - device return status changed from yes to no.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult or delayed activation was unable to be replicated in a testing environment due to the condition of the returned device.The reported defective device shortened was unable to be replicated in a testing environment as the stent was not returned.The reported migration and malposition of stent were unable to be replicated in a testing environment as they were based on operational circumstances.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 incidents from this lot.It is possible that during stent deployment interaction with the anatomy and/or the delivery system was slightly pushed distally as the stent was being deployed resulting in the stent to shorten and slip out of place from the target lesion; thus resulting in the reported stent migration and stent malposition into healthy tissue; however, this could not be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.The treatment appears to be related to the operational context of the procedure as surgery was performed to retrieve the implanted stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.H10: removed type of investigation code 4115 and added 10; removed investigation conclusion code 67 and added 4315; added investigation findings code 114.
Event or Problem Description
N/a.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13308643
• Report Number: 2024168-2022-00686
• Device Sequence Number: 17376802
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2022

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: 12/31/2022
• Device Model Number: S-65-040-120-P6
• Device Catalogue Number: S-65-040-120-P6
• Device Lot Number: 1012161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 03/01/2022; 03/29/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 03/11/2022; 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DESTINATION 6FR 45CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown