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

Catalog Number 1012463-23

Device Problem Physical Resistance (2578)

Patient Problem Prolapse (2475)

Event Date 02/03/2017

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 revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported resistance during advancement and patient effect appears to be related to circumstances of the procedure.Based on the information reviewed, 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 unstable angina.The procedure on (b)(6) 2017 was to treat a lesion located in the distal left anterior descending (lad) artery with soft calcification, long stenosis, ectatic vessel and 85% stenosis.Vessel sizing was performed with angiography and determined to be 3 mm in diameter.Predilatation was performed with two semi-compliant balloons (2.0x30 and 2.5x30) with residual stenosis reduced to less than 40%.After vessel preparation, a 3.0x23mm absorb was advanced to the distal part of the lesion with some difficulty in deliverability causing a plaque shift; however, there were no adverse patient effects.The procedure was successfully completed with 2 absorb overlapped to treat the plaque shift and more proximal area of the lesion.There was a good final patient outcome.There were no reported adverse patient effects or clinically significant delay in 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: 6418723
• MDR Text Key: 70377745
• Report Number: 2024168-2017-02323
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157035
• UDI-Public: (01)08717648157035(17)170710(10)6011361
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2017
• Device Catalogue Number: 1012463-23
• Device Lot Number: 6011361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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): Required Intervention