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

Catalog Number 1012463-28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Hypersensitivity/Allergic reaction (1907); Stenosis (2263)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event - estimate.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.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 effects of angina, hypersensitivity 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 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.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

It was reported that the procedure on (b)(6) 2016 was to treat a 90% stenosis in the left anterior descending artery.Pre-dilatation was done with a 2.0 x 12 mm non-compliant (nc) balloon reducing the stenosis to less than 40%.A 3.0 x 28 mm absorb scaffold was implanted and post-dilated with a 3.0 x 12 mm nc balloon at 18 atm with final residual stenosis less than 10%.The patient began experiencing chest pain in (b)(6) 2016.Angiography was done on (b)(6) 2016 and 95% restenosis was confirmed in the scaffold as well as a 90% stenosis in the right coronary artery.Re-intervention was done on (b)(6) 2016 at which time non-abbott stents were implanted in both vessels for treatment with a good result.It was confirmed that the patient had been compliant with dual antiplatelet therapy after the procedure.The patient further reported that he had developed allergies after implantation of the absorb scaffold which required treatment; however, the physician had no knowledge of this.No additional information was provided.

• 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: 6289888
• MDR Text Key: 66162294
• Report Number: 2024168-2017-00801
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157042
• UDI-Public: (01)08717648157042(17)160816(10)508186A
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2016
• Device Catalogue Number: 1012463-28
• Device Lot Number: 508186A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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: 57 YR