MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1012462-18

Device Problems Difficult or Delayed Positioning (1157); Inflation Problem (1310); Difficult to Remove (1528); Material Rupture (1546)

Patient Problems Air Embolism (1697); Angina (1710); Occlusion (1984)

Event Date 03/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Although the device is not approved for sale in the us, it uses a delivery system which is similar to a device sold in the us.

Event Description

It was reported that the procedure was to treat a lesion located in the diagonal branch.Predilatation was performed with a 2.5 mm balloon at 12-14 atmospheres (atm).A 2.5x18mm implant delivery system was prepped.There were no issues encountered while removing the protective sheath.The device was advanced without resistance and positioned into the target lesion; however, the balloon would not inflate during attempted deployment.While inflating the balloon the pressure could not be raised above 6-7 atm without the balloon leaking.The implant was deployed; however, there was significant resistance in withdrawing the balloon from the implant.After withdrawing the balloon a tiny hole was noted.The patient began experiencing transient chest pain and transient no reflow due to spilling of the balloon content (most probably some air bubble) which was treated with nitrates.The flow got better after 1-2 minutes.Another balloon catheter was advanced and successfully deployed the implant.The final patient outcome was good.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The reported inflation difficulty was confirmed.The reported balloon rupture was not tested due to balloon separation.The reported resistance during removal and implant wall apposition could not be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The reported patient effects of air embolism, occlusion and angina, as listed in the instructions for use (ifu), are known adverse events associated with the use of a coronary implant in native coronary arteries.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded the following: patient has unusual anatomical variant of the coronary vasculature.Implant placement in the first diagonal and in the lad after predilatation followed by post dilatation.No evidence seen on angio of leak with implant #1 as reported.Based on the information reviewed and analysis of the returned device, it is likely the reported inflation issue/balloon leak were due to the damage (balloon break) in the proximal balloon seal; however a conclusive cause for the proximal seal damage cannot be determined.The reported implant wall apposition and resistance during removal appears to be related to the circumstances of the procedure.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: DRUG ELUTING CORONARY 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: 5617831
• MDR Text Key: 43982600
• Report Number: 2024168-2016-02707
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 1012462-18
• Device Lot Number: 412046A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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