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 Angina (1710); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 01/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.The device was not returned for evaluation.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that the patient had returned approximately 4 years post bioresorbable vascular scaffold (bvs) implant in the proximal lad.Initially scaffold was left under-expanded in the mid to proximal vessel.Patient returned with thrombosis in the proximal scaffold and restenosis in the proximal to mid distal scaffold.Restenosis was treated with metallic stent.The investigation determined the reported difficult to deploy (malapposition) and scaffold discontinuities appear to be related to circumstances of the procedure.The reported patient effects and treatments appear to be related to the scaffold malapposition.The reported patient effects of angina, myocardial infarction and thrombosis, as listed in the bvs system, absorb, instructions for use, are known adverse events associated with the use of a coronary scaffold in native coronary arteries.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents from this lot.There is no indication of product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that the procedure on (b)(6) 2013 was to treat a 70% stenosis in the left anterior descending (lad) artery with no calcification or tortuosity, but a presence of thrombus.The patient presented with a non-st elevated myocardial infarction (nstemi).Pre-dilatation was done with a 3.0 x 12 mm trek balloon up to 12 atmospheres (atm) reducing the stenosis to less than 40%.A 3.0 x 18 mm absorb scaffold was implanted reducing the stenosis to less than 10%.Post-dilatation was not performed.No intravascular ultrasound (ivus) or optical coherence tomography (oct) was used to confirm that the scaffold was fully opposed to the vessel wall.The patient returned on (b)(6) 2017 due to oppressive chest pain and stemi.Scaffold thrombosis was found.The thrombus was aspirated and oct showed some late discontinuities that led to malapposition.A 3.0 x 20 mm stent was implanted at 24 atm with a good patient outcome.Prolonged dual antiplatelet drug therapy with prasugrel was recommended.No additional information was provided.

Manufacturer Narrative

(b)(4).

• 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: 6319397
• MDR Text Key: 67091821
• Report Number: 2024168-2017-01103
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157028
• UDI-Public: (01)08717648157028(17)140421(10)3042261
• 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: 02/14/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2014
• Device Catalogue Number: 1012463-18
• Device Lot Number: 3042261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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