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

Catalog Number 1012463-18

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); Prolapse (2475)

Event Date 03/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A drug eluting stent was placed covering all the disease and final result was good.The final patient outcome was good.The ruptured plaque may have been present prior to treatment of the thrombosis but was noted/suspected after treatment.Reportedly, the patient stated he was not compliant with his medication and continued to smoke.He is now on ticagrelor for 12 months and aspiring 81mg indefinitely.No additional information was provided.There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.The ifu states: pre-dilate the lesion with a percutaneous transluminal coronary angioplasty catheter.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.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.

Event Description

It was reported that the patient presented with a st elevated myocardial infarction (stemi).The procedure on (b)(6) 2014 was to treat a de novo lesion located in the mid left anterior descending (lad) artery with 80% thrombosis.Thrombectomy was performed as well as left ventricular, right/left heart catheterization and coronary angiogram.Vessel sizing was performed using fluoroscopy which determined the diameter was greater than 2.5mm.No predilatation was performed.An absorb 3.0x18mm was deployed at 16 atmospheres (atm) for 30 seconds (sec).No post-dilatation was performed.No imaging was performed to confirm that the scaffold was fully apposed to the vessel wall.The patient was put on plavix for 12 months and aspirin 81mg indefinitely.On (b)(6) 2017 the patient presented at the cath lab with a stemi (anterior).The lad was determined to be occluded at the previous absorb implantation site with disease on either side.Thrombectomy was performed in the lad.A 2.5x12mm non-abbott balloon was inflated at 12 atm for 30 sec.Then a 3.75x20mm non-abbott nc balloon was inflated at 20 atm for 15 sec.Then the same balloon was inflated to 24 atm for 15 sec.A 3.5x32mm non-abbott drug eluting stent was then placed in the mid lad at 14 atm for 20 sec.Flow was established with the thrombectomy catheter and a small balloon and reapro was administered.Optical coherence tomography was performed which showed good endotheliazation of the previous absorb, but the proximal edge may have had a ruptured plaque.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• 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: 6497373
• MDR Text Key: 72919371
• Report Number: 2024168-2017-03221
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157028
• UDI-Public: (01)08717648157028(17)150323(10)4071161
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2015
• Device Catalogue Number: 1012463-18
• Device Lot Number: 4071161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 56