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

Catalog Number 1012463-18

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Myocardial Infarction (1969); Thrombosis (2100)

Event Date 09/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.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) 2015 was to treat an 80% stenosis in the proximal left anterior descending artery (lad).The patient presented with unstable angina.Pre-dilatation was performed with a 3.0 x 15 mm semi-compliant balloon, reducing the stenosis to about 10%.The 3.0 x 18 mm absorb scaffold was implanted at 14 atmospheres (atm) and post-dilated with a 3.75 x 15 mm non-compliant balloon up to 18 atm with a good angiographic result.The patient returned (b)(6) 2016 with a non q wave myocardial infarction.There was a timi 3 flow, but both angiography and optical coherence tomography (oct) showed the presence of thrombus.There was proximal malapposition of the scaffold, but the mid and distal parts showed good endothelization.The thrombosis was treated with a 3.5 x 16 mm everolimus eluting stent and post-dilatation was performed with a 4.0 x 12 mm nc balloon.The final outcome was good.The patient was put back on dual antiplatelet therapy (dapt) of aspirin and ticagrelor.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.The cine of the procedure was returned and reviewed by an abbott vascular physician.The reviewer concluded the following: very late scaffold thrombosis (partial without total occlusion and good preservation of flow) most likely due to significant malapposition of struts at the proximal edge.The remainder of the scaffold is widely patent without restenosis.The reported wall apposition and patient effects appear to be related to the circumstances of the procedure.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 myocardial infarction and thrombosis, 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 information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 6042572
• MDR Text Key: 57915685
• Report Number: 2024168-2016-07106
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012463-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• 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; Disability