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

Catalog Number S-50-120-120-P6

Device Problem Detachment Of Device Component (1104)

Patient Problems Occlusion (1984); Perforation (2001); Thrombosis (2100); Foreign Body In Patient (2687)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The next day she had symptoms of re-occlusion, and a femoral-popliteal bypass and thrombectomy of the tibial vessels were performed.The patient was kept for a few days and was released on (b)(6) 2017.No additional information provided.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the in (b)(6) 2016, the patient had balloon angioplasty performed on the lesion in the popliteal artery with a drug coated balloon.The patient returned to the hospital on (b)(6) 2017 and angiography confirmed that the lesion had become re-occluded.A non-abbott 018 guide wire was advanced to the lesion and inadvertently perforated the artery and the distal end was extravascular.This was not noticed at the time.A 5.0 x 120 mm supera peripheral stent delivery system (sds) was advanced over the guide wire and the stent implant was deployed with no issues noted.Following deployment of the stent and removal of the sds from the anatomy, it was observed that the approximately 5 cm of the stent was extravascular, enlarging the perforation caused by the guide wire.The tip of the sds had separated and was also extravascular in the soft tissue of the knee joint.The tip was not able to be retrieved; therefore, it was left in the anatomy.The stent being deployed across the vessel and partially extravascular was a causing blood flow issue.A surgeon was consulted, who advised that if flow could be restored, open bypass could be avoided.An unspecified guide wire was then advanced through the struts of the supera stent implant into the true lumen of the popliteal artery.Two non-abbott stent grafts were deployed into the supera stent and through the struts in order to open up the artery and seal the perforation.This restored the flow with decent runoff.The patient was admitted for observation.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.It is likely that supera was advanced over the portion of the guide wire that was extravascular resulting in a portion of the stent deploying extravascular causing the perforation to enlarge.Additionally, with a portion of the stent deployed extravascular, it is likely that the tip was unable to pass through the reduced clearance of the stent causing the tip to detach during deployment when the thumbslide strokes were being performed.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 revealed no other incident reported from this lot.The investigation determined that the tip detachment and subsequent patient effects were due to case circumstances.The reported patient effects of perforation, thrombosis, occlusion, and surgical procedure are listed in the supera instruction for use as known potential adverse events associated with the use of the device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6750799
• MDR Text Key: 81290866
• Report Number: 2024168-2017-06256
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 6081761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 10/12/2017
• Supplement Dates FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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: GUIDE WIRE: BOSTON SCIENTIFIC 018
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 68 YR
• Patient Weight: 101