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

Catalog Number 1012464-28

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 06/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The two absorb devices will be filed under separate medwatch manufacturer report reference numbers.

Event Description

It was reported that the patient was stented in 2009 in another hospital with non-abbott stents unknown type and sizes, then was re-stented on (b)(6) 2013 in the right coronary artery (rca) with 3 absorb stents for treatment of restenosis (3.5 x 28 distal , 3.5 x 28 mid and a 3.5 x 18 proximally).Prior to the initial procedure the patient's clinical presentation was severe angina.The patient presented to the cath lab with stable angina on (b)(6) 2018 and it was discovered that the rca was re-stenosed.Optical coherence tomography confirmed that all the absorb stents were all fully resorbed and found a tight fibrous plaque along the rca.An nc trek was used for pre-dilatation, then a cutting balloon and a 3.75 nc trek and finally a 4.0 cutting balloon were used to prepare the rca before stenting with a 3.5 x 38 xpedition distal and 3.5 x 28 xpedition proximally with great results.It was confirmed that patient was on dual antiplatelet therapy at last visit with doctor in 2016.No issues occurred and patient was stable.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: lot number unknown.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 numbers were not provided.The reported patient effects of angina and restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) are known adverse events associated with the use of a coronary scaffold in native coronary arteries.It should be noted that the ifu states: the absorb bvs is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions.It is unknown if the ifu deviation contributed to the reported difficulty.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: 7700499
• MDR Text Key: 114403404
• Report Number: 2024168-2018-05586
• Device Sequence Number: 1
• Product Code: PNY
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012464-28
• Device Lot Number: 3070661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2018
• 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
• Patient Age: 74 YR
• Patient Weight: 79