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

Catalog Number 1012462-18

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Angina (1710); Stenosis (2263)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.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 investigation determined the reported difficult to deploy (under expansion) appears to be related to circumstances of the procedure.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.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 manufacture, design or labeling.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 stable angina.The index procedure on (b)(6) 2015 was to treat a lesion located in the mid left anterior descending (lad) artery with mild calcification and 50% stenosis.Vessel sizing was performed with qualitative coronary angiography with the vessel determined to be greater than 2.5 mm.Predilatation was performed with a 2.5 x 15 mm non-abbott balloon catheter with the residual stenosis reduced to less than 40%.A 2.5 x 18 mm absorb was implanted and post-dilatation was performed with a 2.5 x 15 mm non-abbott balloon catheter at 20 bar.Angiography noted the calcification was not fully open; however, the scaffold appeared to be apposed to the vessel wall.Additional post-dilatation was performed; however, the calcified lesion was not fully open.Residual stenosis was almost 10%.The patient returned on (b)(6) 2017 with chest pain and under angiography, in-scaffold restenosis was identified in the lad.A check by intravascular ultrasound determined the lumen was 1.9 mm and the vessel size was 3.0.The restenosis was treated with the implantation of a 2.5 x 26 mm non-abbott stent and post-dilatation with a 2.75 x 12 mm nc non-abbott balloon catheter.The final result was good.The patient was confirmed to have been compliant with their dual antiplatelet drug therapy (dapt) consisting of plavix and aspirin after the index procedure.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: 6733650
• MDR Text Key: 80703529
• Report Number: 2024168-2017-06099
• 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
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012462-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• 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: 56 YR
• Patient Weight: 70