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

Catalog Number 1234350-18

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2017

Event Type  malfunction  

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.Based on the information reviewed, a conclusive cause for the reported difficulty to deploy could not be determined.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 incidents from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the patient presented with severe chest pain.The procedure on (b)(6) 2017 was to treat a lesion located in the proximal to mid left anterior descending (lad) artery with a chronic total occlusion.Vessel sizing was performed with intra-vascular ultrasound which determined that the vessel size was 3.5mm.Pre-dilatation of the mid lad was performed with a 3.0x12mm nc trek with residual stenosis reduced to less than 10%.A 3.0x18mm absorb gt1 was implanted smoothly.A second absorb gt1 (3.5x18mm) was advanced for overlap with the first 3.0x18mm absorb gt1; however, during expansion of the 3.5x18mm absorb gt1, the scaffold suddenly retreated from the original location.The scaffold was deployed partially in the target lesion; however, the scaffold edge was found to be protruding 3mm into the left circumflex.Timi blood flow was 3 and the patient was without any discomfort.The patient was discharged on dual anti-platelet therapy (dapt) on (b)(6) 2017.On the third day after discharge, (b)(6) 2017, the patient went back to the hospital with a severe headache.A brain computer tomography was performed and an intracranial hemorrhage was identified.The consulting neurological surgeon stated the intracranial hemorrhage was caused by taking ticagrelor.The patient's dapt was stopped to avoid expanding the intracranial hemorrhage range.The patient's vital signs are stable and the intracranial hemorrhage is controlled but not resolved.The patient is hospitalized in the intensive care unit for observation.If the patient's condition is stable, the patient is expected to be discharged on (b)(6) 2017.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: 6567291
• MDR Text Key: 75319590
• Report Number: 2024168-2017-04151
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648212888
• UDI-Public: (01)08717648212888(17)180103(10)7010461
• 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: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2018
• Device Catalogue Number: 1234350-18
• Device Lot Number: 7010461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• 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: SCAFFOLD: ABSORB GT1 3.0X18
• Patient Age: 58 YR