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

Catalog Number 42055060-120

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2021

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a moderately tortuous, heavily calcified, chronically totally occluded restenosed superficial femoral artery (sfa).Pre-dilatation was performed with 4 mm, 5 mm and 6 mm balloons.Initially, a supera stent and non-abbott stent were deployed at the lesion without issue.Then a 5.5x60mm supera stent was advanced to the lesion and deployment was initiated (stent intended to overlap the first previously placed stents), however, it was difficult to see the supera stent placement and thus it was deployed overlapping within a previously placed non-abbott stent due to bad imaging.The introducer sheath was far away from the proximal end of the stent during deployment.When the supera system was attempted to be removed, it was inadvertently pulled too high up and about 20-30% of the supera stent was deployed within the non-abbott stent (proximal sfa) and 70-80% still in the introducer sheath.A cut-down surgery was performed to successfully retrieve the supera stent leaving the treated vessel fine.There was a clinically significant delay.The patient was discharged the day after the procedure without issue.No additional information was provided.Case description for final eumir: it was reported that the procedure was to treat a moderately tortuous, heavily calcified, chronically totally occluded restenosed superficial femoral artery (sfa).A supera stent was advanced to the lesion and deployment was initiated, however, it was difficult to see the supera stent placement and thus it was deployed overlapping within a previously placed non-abbott stent due to bad imaging.When the supera system was attempted to be removed, it was inadvertently pulled too high up and about 20-30% of the supera stent was deployed within the non-abbott stent (proximal sfa) and 70-80% still in the introducer sheath.A cut-down surgery was performed to successfully retrieve the supera stent leaving the treated vessel fine.The account confirmed that there was a clinically significant delay as the patient was admitted to the hospital for 5 days of observation.Subsequent to the initially filed eu mir report, the account confirmed pre-dilatation was performed with a 4 mm, 5 mm and 6 mm balloons.The introducer sheath was far away from the proximal end of the stent during deployment.Additionally, a prior supera was implanted before the 5.5x60mm supera, as the complaint device was supposed to overlap the first supera by 1cm.The patient was discharged the day after the procedure without issue and did not stay for 5 days of observation as previously reported.

Manufacturer Narrative

The device is retained by hospital and not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a moderately tortuous, heavily calcified, chronically totally occluded restenosed superficial femoral artery (sfa).Pre-dilatation was performed with 4 mm, 5 mm and 6 mm balloons.Initially, a supera stent and non-abbott stent were deployed at the lesion without issue.Then a 5.5x60mm supera stent was advanced to the lesion and deployment was initiated (stent intended to overlap the first previously placed stents), however, it was difficult to see the supera stent placement and thus it was deployed overlapping within a previously placed non-abbott stent due to bad imaging.The introducer sheath was far away from the proximal end of the stent during deployment.When the supera system was attempted to be removed, it was inadvertently pulled too high up and about 20-30% of the supera stent was deployed within the non-abbott stent (proximal sfa) and 70-80% still in the introducer sheath.A cut-down surgery was performed to successfully retrieve the supera stent leaving the treated vessel fine.There was a clinically significant delay.The patient was discharged the day after the procedure without issue.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the lot number was not provided.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that due to bad imaging the supera stent was inadvertently deployed overlapping within a previously placed non-abbott stent resulting in the reported difficult or delayed positioning, activation failure including expansion failures and entrapment of device as about 20-30% of the supera stent was deployed within the non-abbott stent.The treatments appears to be related to the operational context of the procedure as a cut-down surgery was performed to successfully retrieve the supera stent leaving the treated vessel fine.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: 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: 12837970
• MDR Text Key: 284690909
• Report Number: 2024168-2021-10589
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 42055060-120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 12/30/2021
• Supplement Dates FDA Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EVERFLEX STENT; SUPERA STENT; TERUMO SHORT 6F SHEATH
• Patient Outcome(s): Required Intervention