MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number 1012532-80

Device Problems Difficult or Delayed Positioning (1157); Physical Resistance (2578); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: guide wire: gradius, piolax surf, sheath: allow flex sheath 7fr 35 cm.The device was received.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 de novo lesion in a mildly calcified, concentric, heavily tortuous, common iliac artery with 100% stenosis.Thrombus was discovered in a femorofemoral bypass (f-f), which was found to be occluded.A 7fr sheath was inserted into the left common femoral artery (cfa).Thrombus was aspirated with a non-abbott catheter.To treat the lesion, a chronic total occlusion percutaneous coronary intervention (cto pci) was performed.A non-abbott guide wire (gw) was advanced (ipsilateral retrograde approach).The gw crossed the left cto lesion.A 10x 80mm absolute pro stent delivery system was advanced to the lesion.During deployment, resistance was met when rotating the thumbwheel.The gw was then replaced with another non-abbott gw to continue.Another attempt was then made to deploy the absolute pro stent.The proximal end of the stent was implanted at the intended position.However, the distal part of the stent was implanted more distally than expected.The stent was then noted to have been deployed in a position where it protruded into the aorta.The stent was stretched and there was concern that the stretched area might be weakened; therefore, an additional non-abbott stent was deployed in the stretched area of the absolute pro to successfully complete the procedure.Post-dilatation was performed with a 8 x 40mm armada 35 balloon dilatation catheter.Then a femoral popliteal bypass surgery was performed, but was not related to the stent deployment issues with the absolute pro.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Chemical analysis of the device was performed which indicates that there was no evidence of adhesive accelerator loctite on the paw tab surfaces.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device by abbott vascular (av).The deployment issue, resistance and stretching could not be confirmed as the stent had been fully deployed and was not returned.The reported "lack of clicking" sound was due to the ratchet paw missing, which appears to be related to a potential product quality issue.A review of the lot history record revealed no associated nonconforming material records (ncmr).A query of the complaint database for the reported lot was performed and revealed no other similar incidents from this lot reported.The investigation was unable to determine a cause for the reported resistance, deployment issue and stretched stent.The missing ratchet paw appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.

Event Description

Additional information attained from account states that the ticktock sound was not heard, however a different sound was heard.

Manufacturer Narrative

(b)(4).A visual inspection was performed on the returned device.The deployment difficulty, resistance and stretched stent were not confirmed as the stent had been fully deployed and was not returned.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 of the reported lot revealed no other similar incidents.The investigation was unable to determine a cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ABSOLUTE PRO VASCULAR 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: 7433379
• MDR Text Key: 105583973
• Report Number: 2024168-2018-02807
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 1012532-80
• Device Lot Number: 7081661
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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
• Patient Outcome(s): Required Intervention