MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1234300-28

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

Patient Problems Intimal Dissection (1333); Thrombosis (2100)

Event Date 08/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant product: stent: 3.0 x 12mm xience; scaffold: absorb gt1 3.0 x 23 mm.The absorb gt1 3.0 x 23 mm referenced is being filed under a separate manufacturer report number.The scaffold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure on (b)(6) 2016 was to treat a moderately calcified lesion in the mid left anterior descending artery.Pre-dilatation was performed with a 2.5 x 20 mm balloon and two absorb gt1 scaffolds (3.0 x 23mm, 2.5 x 23 mm) were implanted overlapping at 14 atmospheres (atm).Post-dilatation was done with a 3.0 x 20 mm balloon at 18 atm at which time a dissection occurred at the proximal edge of the proximal 2.5 x 23 mm scaffold.A 3.0 x 12 mm xience stent was implanted overlapping part of the proximal scaffold.The patient returned on (b)(6) 2016.Optical coherence tomography (oct) did not show any malposition, but thrombus was found in the scaffolded area.A xience prox stent was implanted for treatment.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 cine was received and reviewed by an abbott vascular clinical specialist who concluded: documented thrombosis present in the lad of two previously deployed absorb scaffolds with a patent proximal metallic stent.Vessel is re-treated with two metallic stents.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, dissection and thrombosis, 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.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.

Event Description

Subsequent to the previously filed medwatch report, there was a correction to the event: the patient presented with a st elevated myocardial infarction.The first scaffold implanted was a 2.5 x 23 mm absorb, not an absorb gt1 as initially reported.A 3.0 x 28 mm absorb gt1, (not a 3.0 x 23 mm as initially reported), was implanted proximally.The dissection occurred at the proximal end of this scaffold.The patient returned due to angina.Timi 3 flow was restored after the thrombosis was treatment with the xience prox stent.There was a good final patient outcome it was confirmed that the patient had been compliant with dual antiplatelet drug therapy (dapt) of aspirin and prasugrel.No additional information was provided.

• Brand Name: ABSORB GT1 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: 6201388
• MDR Text Key: 63175763
• Report Number: 2024168-2016-09211
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2017
• Device Catalogue Number: 1234300-28
• Device Lot Number: 5112461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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