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

Catalog Number 1235250-28

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

Patient Problem Perforation (2001)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The additional 2.5 x 28 mm absorb gt1 scaffold referenced is being filed under a separate manufacturer report number.Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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.The reported patient effect of perforation, as listed in the absorb gt1 instructions for use (ifu), is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

It was reported that the procedure on (b)(6) 2016 was to treat the distal and proximal right coronary artery.Two 2.5 x 28 mm absorb gt1 scaffolds were deployed.As post-dilatation was done in the mid section of the distally deployed scaffold a perforation occurred.Another non-compliant (nc) balloon was used to post-dilate the mid part with good results.While removing the nc balloon catheter a dissection occurred in the proximally deployed scaffold.A 2.75 x 18 mm xience v stent was implanted to cover the dissection.The final outcome was good.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: 6216628
• MDR Text Key: 63691596
• Report Number: 2024168-2016-09421
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648212987
• UDI-Public: (01)08717648212987(17)180410(10)6101361
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2018
• Device Catalogue Number: 1235250-28
• Device Lot Number: 6101361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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
• Treatment: OTHER: 2.5 X 28 MM ABSORB GT1 SCAFFOLD
• Patient Outcome(s): Required Intervention