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

Catalog Number S-50-120-120-P6

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Failure to Advance (2524)

Patient Problem Occlusion (1984)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4)-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 is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a 5mm heavily calcified lesion in the superficial femoral artery.A 6f 40 cm non-abbott sheath was placed.Atherectomy and balloon angioplasty with an unspecified 5.0 balloon catheter were performed.Despite the balloon catheter being inflated for 2 mins to rate of burst pressure, the proximal part of the lesion remained heavily calcified and difficult to cross.A 5.0 x 120 mm supera self expanding stent system (sess) was advanced but could not cross the lesion due to the patient anatomy.The sess was removed and further balloon angioplasty was performed by a 5.0 x 20 mm unspecified focal balloon catheter.The sess was attempted to be readvanced; however, failed to cross the lesion again.On removal attempt of the sess, resistance was met and the tip of the sess was noted to stretch.Despite no force being applied, the nose cone separated and remained entrapped in the patient anatomy.No attempts to snare the separated tip were made due to a concern that the tip would migrate and risk occluding the distal arteries.An angiogram performed 15 minutes post separation noted the nose cone was already causing a significant impact on flow.The patient declined a surgical bypass procedure and was discharged home.Three days post procedure, the patient was readmitted and underwent a surgical bypass and the tip of the 5.0 x 120 mm supera sess was removed.The patient was reported to be doing well post procedure.No additional information was provided.

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.Visual analysis was performed on the returned device.The reported stretched and separated tip were confirmed.The failure to advance, difficulty removing, and entrapment was not tested as it was based on procedural 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 similar complaints.The reported patient effect of occlusion is listed in the supera instructions for use (ifu) as a known patient effect associated with the use of the device.The investigation concluded that the reported difficulties were due to case circumstances.The challenging anatomy resulted in the failure to cross and caused the tip to become entrapped and separate during the attempt to withdraw the delivery system.As a result, the separated nose cone was causing a significant impact on flow requiring additional hospitalization and surgery to remove the separated tip.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA PERIPHERAL STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8908638
• MDR Text Key: 154867100
• Report Number: 2024168-2019-10961
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211775
• UDI-Public: 08717648211775
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 9010761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6F 40CM DESTINATION SHEATH.
• Patient Outcome(s): Hospitalization; Required Intervention; Disability