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

Catalog Number 1012462-28

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

Patient Problems Angina (1710); Stenosis (2263)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Absorb scaffold implanted in a vessel less than 2.5mm diameter.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.

Event Description

It was reported that the procedure on (b)(6) 2015 was to treat a lesion located in the proximal left anterior descending (lad) artery with 79% eccentric stenosis.Vessel sizing was performed with angiography and determined that the vessel was less than 2.5mm.Predilatation was performed with a 2.5x20mm non-abbott balloon at 10 atmospheres (atm), resulting in 59% residual stenosis.A 2.5x28mm absorb was implanted followed by post-dilatation with a 2.5x15mm non-abbott high pressure balloon at 20 atm.No imaging was performed to confirm the absorb scaffold was fully apposed to the vessel wall.The patient returned on (b)(6) 2015 for a regular follow-up and was prescribed plavix and aspirin for three months per protocol.On (b)(6) 2018, the patient presented with angina and the absorb scaffold was identifed with restenosis and was treated with the implantation of a xience stent.The patient was confirmed to have been compliant with their dual anti-platelet therapy.The final patient outcome was good with timi 3 flow.No additional information was provided.

Manufacturer Narrative

(b)(4).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 and complaint history of the reported device could not be conducted because the lot number was not provided.The reported patient effects of angina and restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information, 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.

• 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: 7265359
• MDR Text Key: 99879104
• Report Number: 2024168-2018-01028
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012462-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention